Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=72
{ "count": 4826, "next": "http://api.gregory-ms.com/trials/?format=api&page=73", "previous": "http://api.gregory-ms.com/trials/?format=api&page=71", "results": [ { "trial_id": 3633, "title": "CDP323 Biomarker Study", "summary": null, "published_date": "2008-07-29T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.707258Z", "link": "http://clinicaltrials.gov/show/NCT00726648", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00726648" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "4645118", "last_refreshed_on": "2015-02-19", "scientific_title": "Double-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability.", "primary_sponsor": "UCB Pharma", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "Both", "date_enrollement": "2008-07-15", "target_size": "71", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science", "phase": "Phase 1/Phase 2", "countries": "United Kingdom", "contact_firstname": "", "contact_lastname": "UCB Clinical Trial Call Center", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "UCB Pharma", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Female and male subjects aged 18-65 years\r<br>\r<br> - Relapsing form of MS with at least one clinical relapse in the 24 months before\r<br> screening;\r<br>\r<br> - Screening EDSS score of 0-6.5;\r<br>\r<br> - Must be fully immunocompetent\r<br>\r<br> - Female subjects of childbearing potential must agree to practice contraception\r<br> methods\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any conditions that could interfere with the contrast-enhanced MRI;\r<br>\r<br> - Any clinically significant disease state or findings other than MS;\r<br>\r<br> - Any clinically significant deviation from the pre-defined ranges for laboratory\r<br> tests;\r<br>\r<br> - Concomitant treatment with MS disease modifying drugs\r<br>", "exclusion_criteria": null, "condition": "Relapsing Multiple Sclerosis", "intervention": "Drug: CDP323;Drug: CDP323;Drug: CDP323;Drug: CDP323;Drug: Placebo", "primary_outcome": "Pharmacodynamic parameters related to leukocyte trafficking", "secondary_outcome": "Standard and disease-related safety variables;Class-related safety parameters", "secondary_id": "EudraCT 2008-000147-34;IND 74863;C32325", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3632, "title": "A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFR", "summary": null, "published_date": "2008-07-29T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.685227Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002560-34", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-002560-34-BE" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "2471855", "last_refreshed_on": "2012-03-19", "scientific_title": "A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFR", "primary_sponsor": "Eli Lilly and Company", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2008-02-09", "target_size": "238", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: yes\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no", "phase": null, "countries": "Belgium", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>[1] Present with central neuropathic pain due to MS based on the disease diagnostic criteria<br>[2] Are male or female outpatients at least 18 years of age at the time of consent<br>[3] Have a score of 4 or greater on the daily 24-hour average pain score (0-<br>10) for at least 4 of the 7 days prior to Visit 2<br>[4] Females must test negative for pregnancy at Visit 1. Females of childbearing potential must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study drug<br>[5] Have an educational level and degree of understanding such that the patient can communicate intelligibly<br>[6] Are judged to be reliable and agree to keep all appointments for clinic<br>visits, tests, and procedures required by the protocol<br>[7] Complete the daily diaries for at least 70% of the days between Visit 1 and Visit 2<br>[8] Patients may continue other prescription and non-prescription analgesic<br>medications as long as the dose has been stable for 1 month prior to<br>Visit 1, and they agree to maintain that stable dose throughout the study. Patients will NOT be allowed to change doses of concomitant analgesics<br>during the study<br>[9] Diagnosis of MS at least 1 year prior to Visit 1 as determined by MacDonald or Poser criteria.<br>[10] Clinical stability as determined by an absence of MS exacerbation or<br>change in disease modifying therapy for the 3 months prior to Visit 1.<br>[11] Daily central neuropathic pain due to MS present for a minimum of 3 months prior to Visit 1<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>[12] Are investigator site personnel directly affiliated with this study and/or their immediate families<br>[13] Are Lilly employees<br>[14] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry<br>[15] Are currently in a clinical trial of MS disease-modifying therapy<br>[16] Have pain that cannot be clearly differentiated from causes other than MS<br>[17] Have previously completed this study, withdrawn from any duloxetine study, or have been intolerant to previous duloxetine treatment. Note: Patients who have screen-failed for the reason of previous exposure to duloxetine may be reconsidered for this study.<br>[18] Have previously demonstrated lack of response to an adequate trial of duloxetine per investigator opinion.<br>[19] Are unwilling to comply with the use of a data collection device to directly record data from the patient. For those patients who do not have enough fine motor control to enter data directly into the device, a designated assistant may be used for data entry. The assistant must be the same person for all data entries. The designated assistant may not be site personnel or personnel affiliated with the study.<br>[20] Any current or historical DSM-IV diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder<br>[21] History of DSM-IV-TR substance abuse or dependence within the 6<br>months immediately prior to Visit 1, excluding nicotine and caffeine. For purposes of this study, prior or current use (at Visit 1) of dronabinol (Saltivex) for MS or MS pain will not be considered to meet the DSm-IV criteria for substance abuse. However, use of this medication may be subject to other restrictions (see concomitant medication list for excluded medications).<br>[22] Are taking any excluded medications that cannot be discontinued at<br>Visit 1 (see concomitant medication list for excluded medications).<br>[23] Have had treatment with a MAOI within 14 days of randomization or<br>the potential need to use an MAOI during the study or within 5 days of<br>discontinuation of study drug<br>[24] Have a positive urine drug screen for any substance of abuse or excluded<br>medication<br>[25] Are pregnant or breast-feeding<br>[26] Have serious cardiovascular, hepatic, renal, respiratory, or hematologic<br>illness, or other medical or psychiatric condition that, in the opinion of<br>the investigator, would compromise participation or be likely to lead to<br>hospitalization during the course of the study.<br>[27] Have elective surgery planned during the trial.<br>[28] Have a history of recurrent seizures other than febrile seizures.<br>[29] Are judged clinically by the investigator or are identified by the C-SSRS or BDI-II question 9 to be at suicidal risk prior to starting study drug. Patients will need to be evaluated by the investigator and/or a psychiatrist if they exhibit suicidality as assessed by the C-SSRS or BDI-II question 9 at any time after randomization.<br>[30] Have uncontrolled narrow-angle glaucoma.<br>[31] Have acute liver injury or severe cirrhosis <br>[32] Have known hypersensitivity to duloxetine or any of the inactive ingredients<br>[33] Have frequent or severe allergic reactions to multiple medications<br>[34] Current DSM-IV-TR Axis I alcohol or eating disorders or PTSD as determined either by patient history or by diagnosis using specific modules of the MINI<br>", "condition": "Central neuropathic pain due to Multiple sclerosis <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10054095\nTerm: Neuropathic pain", "intervention": "<br>Trade Name: Cymbalta<br>Product Name: Duloxetine<br>Product Code: LY248686<br>Pharmaceutical Form: Gastro-resistant capsule, hard<br>INN or Proposed INN: DULOXETINE<br>CAS Number: 116539594<br>Current Sponsor code: LY248686<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 30-<br>Pharmaceutical form of the placebo: Gastro-resistant capsule, hard<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: to assess the efficacy of duloxetine 60 mg once daily (QD) compared with placebo on the reduction of central neuropathic pain severity as measured by the weekly mean of the daily 24-hour average pain scores in patients with central neuropathic pain due to MS assessed using an 11-point Likert scale and collected via daily patient diary at the end of 6 weeks of treatment.;Secondary Objective: • To evaluate response to treatment with duloxetine versus placebo using 2<br>response criteria, a 30% or 50% reduction, in the weekly 24-hour average pain scores described in the primary objective<br>• To assess the efficacy of duloxetine versus placebo as measured by:PGI-Improvement scale,the weekly mean of the 24-hour worst, least, and night pain scores assessed using an 11-point Likert scale and collected via daily patient diary,BPI– Severity and Interference,CGI-Severity<br>• To assess the impact of treatment with duloxetine versus<br>placebo on patient-reported health outcomes, as measured by the MS-QOL-54<br>• To assess the safety of duloxetine versus placebo treatment-emergent adverse events, discontinuation adverse events, solicited questioning of suicide-related events, and suicide risk as assessed the C-SSRS, laboratory assessments, and vital signs.;Primary end point(s): The primary efficacy measure is the weekly mean of the 24-hour average pain severity assessed daily by each patient, via daily diary, using an 11-point Likert scale.", "secondary_outcome": null, "secondary_id": "F1J-US-HMFR(b)", "source_support": null, "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3631, "title": "Oral Cladribine in Early Multiple Sclerosis (MS)", "summary": null, "published_date": "2008-07-30T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.659796Z", "link": "https://clinicaltrials.gov/show/NCT00725985", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00725985" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "6612040", "last_refreshed_on": "2017-12-16", "scientific_title": "A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS", "primary_sponsor": "EMD Serono", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "Yes", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2008-12-31", "target_size": "617", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).", "phase": "Phase 3", "countries": "United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;United States;Saudi Arabia;United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;United States;Saudi Arabia;United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;United States;Saudi Arabia;United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;United States;Saudi Arabia;United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;United States;Saudi Arabia", "contact_firstname": "; ; ; ;", "contact_lastname": "Bettina Stubinski, MD;Bettina Stubinski, MD;Bettina Stubinski, MD;Bettina Stubinski, MD;Bettina Stubinski, MD", "contact_address": null, "contact_email": ";;;;", "contact_tel": ";;;;", "contact_affiliation": "Merck Serono S.A., Geneva;Merck Serono S.A., Geneva;Merck Serono S.A., Geneva;Merck Serono S.A., Geneva;Merck Serono S.A., Geneva", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Male or female between 18 and 55 years old, inclusive\r<br>\r<br> - Weighed between 40 to 120 kilogram (kg), inclusive\r<br>\r<br> - Subject has experienced a single, first clinical event suggestive of MS within 75 days\r<br> prior to the Screening visit, (clock starts 24 hours after onset). The event must be a\r<br> new neurological abnormality present for at least 24 hours, either mono- or\r<br> polysymptomatic\r<br>\r<br> - Subject has at least two clinically silent lesions on the T2-weighted MRI scan, at\r<br> screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid\r<br> or periventricular or infratentorial on screening MRI\r<br>\r<br> - Subject has EDSS 0 - 5.0 at Screening\r<br>\r<br> - Subject has no medical history or evidence of latent tuberculosis infection (LTBI) or\r<br> active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or\r<br> a comparable sensitive test according to local regulations/guidelines (if the Mantoux\r<br> test is not available), and/or a chest X-ray\r<br>\r<br> - Subject has normal hematological parameters at Screening, as defined by the central\r<br> laboratory that performed all the assessments\r<br>\r<br> - If female, she must:\r<br>\r<br> - be neither pregnant nor breast-feeding, nor attempting to conceive and\r<br>\r<br> - use a highly effective method of contraception throughout the entire duration of\r<br> the study and for 90 days following completion of the last dose of study\r<br> medication. A highly effective method of contraception is defined as those which\r<br> result in a low failure rate (that is less than 1 percent per year) when used\r<br> consistently and correctly such as implants, injectables, combined oral\r<br> contraceptives, some intrauterine devices, sexual abstinence or vasectomized\r<br> partner, or\r<br>\r<br> - be post-menopausal or surgically sterilized (Note: for Danish sites only,\r<br> subjects should use a hormonal contraceptive or intrauterine device for the\r<br> duration of the trial)\r<br>\r<br> - Male subjects must be willing to use contraception to avoid impregnating partners\r<br> throughout the study, and for 90 days following the last dose of study medication\r<br>\r<br> - Be willing and able to comply with study procedures for the duration of the study\r<br>\r<br> - Subject has to provide written informed consent voluntarily, including, for United\r<br> states of America (USA), subject authorization under Health Insurance Portability and\r<br> Accountability Act (HIPAA), prior to any study-related procedure that is not part of\r<br> normal medical care\r<br>\r<br> - Subject has refused any treatment already available for clinically isolated syndrome\r<br> (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial\r<br> Treatment Period of this study\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Subject has a diagnosis of MS (per McDonald criteria, 2005)\r<br>\r<br> - Subject has any other disease that could better explain the subject's signs and\r<br> symptoms\r<br>\r<br> - Subject has complete transverse myelitis or bilateral optic neuritis\r<br>\r<br> - Subject using or has used any other approved MS disease modifying drug (DMD)\r<br>\r<br> - Subject has used any investigational drug or undergone an experimental procedure\r<br> within 12 weeks prior to Study day 1\r<br>\r<br> - Subject received oral or systemic corticosteroids or adrenocorticotropic hormone\r<br> (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days\r<br> after the oral or systemic corticosteroids or ACTH treatment. In case this interfered\r<br> with MRI timing the screening period could be extended accordingly.\r<br>\r<br> - Subject has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine\r<br> aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit\r<br> of normal\r<br>\r<br> - Subject suffered from current autoimmune disease other than MS\r<br>\r<br> - Subject suffered from psychiatric illness (including history of, or concurrent, severe\r<br> depressive disorders and/or suicidal ideation) that in the opinion of the investigator\r<br> creates undue risk to the subject or could affect compliance with the study protocol\r<br>\r<br> - Subject suffered from major medical illness such as cardiac (for example angina,\r<br> congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic,\r<br> metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease\r<br> that would preclude the administration of oral cladribine\r<br>\r<br> - Subject has a history of seizures not adequately controlled by medications\r<br>\r<br> - Subject has a known allergy to cladribine, interferon-beta, the excipient(s) of the\r<br> study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA)\r<br>\r<br> - Subject has any renal condition that would preclude the administration of gadolinium\r<br> (for example acute or chronic severe renal insufficiency (glomerular filtration rate\r<br> [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2])\r<br>\r<br> - Subject has a history of chronic or clinically significant hematological abnormalities\r<br>\r<br> - Subject has a history of active or chronic infectious disease or any disease that\r<br> compromises immune function (for example human immunodeficiency virus positive [HIV+],\r<br> human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection\r<br> [LTBI] or TB, insulin-dependent diabetes).\r<br>\r<br> - Subject has previously been screened in this study (signed an informed consent) and\r<br> then withdrawn\r<br>\r<br> - Subject has received any immunomodulatory or immunosuppressive therapy) at any time\r<br> prior to Study Day 1, including, but not limited to, the following products: any\r<br> interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine,\r<br> methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod,\r<br> cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment\r<br> (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4\r<br> [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy\r<br>\r<br> - Subject has received experimental MS treatment\r<br>\r<br> - Subject has a history of alcohol or drug abuse\r<br>\r<br> - Subject has intolerance or any contraindication to both paracetamol (acetaminophen)\r<br> and ibuprofen\r<br>\r<br> - Subject has inability to administer subcutaneous injections either by self or by\r<br> caregiver\r<br>\r<br> - Subject has prior or current malignancy (with the exception of in situ basal or\r<br> squamous cell skin cancer surgically removed without recurrence for at least five\r<br> years)\r<br>\r<br> - Subject has a positive stool hemoccult test at Screening\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Male or female between 18 and 55 years old, inclusive\r<br>\r<br> - Weighed between 40 to 120 kilogram (kg), inclusive\r<br>\r<br> - Subject has experienced a single, first clinical event suggestive of MS within 75 days\r<br> prior to the Screening visit, (clock starts 24 hours after onset). The event must be a\r<br> new neurological abnormality present for at least 24 hours, either mono- or\r<br> polysymptomatic\r<br>\r<br> - Subject has at least two clinically silent lesions on the T2-weighted MRI scan, at\r<br> screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid\r<br> or periventricular or infratentorial on screening MRI\r<br>\r<br> - Subject has EDSS 0 - 5.0 at Screening\r<br>\r<br> - Subject has no medical history or evidence of latent tuberculosis infection (LTBI) or\r<br> active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or\r<br> a comparable sensitive test according to local regulations/guidelines (if the Mantoux\r<br> test is not available), and/or a chest X-ray\r<br>\r<br> - Subject has normal hematological parameters at Screening, as defined by the central\r<br> laboratory that performed all the assessments\r<br>\r<br> - If female, she must:\r<br>\r<br> - be neither pregnant nor breast-feeding, nor attempting to conceive and\r<br>\r<br> - use a highly effective method of contraception throughout the entire duration of\r<br> the study and for 90 days following completion of the last dose of study\r<br> medication. A highly effective method of contraception is defined as those which\r<br> result in a low failure rate (that is less than 1 percent per year) when used\r<br> consistently and correctly such as implants, injectables, combined oral\r<br> contraceptives, some intrauterine devices, sexual abstinence or vasectomized\r<br> partner, or\r<br>\r<br> - be post-menopausal or surgically sterilized (Note: for Danish sites only,\r<br> subjects should use a hormonal contraceptive or intrauterine device for the\r<br> duration of the trial)\r<br>\r<br> - Male subjects must be willing to use contraception to avoid impregnating partners\r<br> throughout the study, and for 90 days following the last dose of study medication\r<br>\r<br> - Be willing and able to comply with study procedures for the duration of the study\r<br>\r<br> - Subject has to provide written informed consent voluntarily, including, for United\r<br> states of America (USA), subject authorization under Health Insurance Portability and\r<br> Accountability Act (HIPAA), prior to any study-related procedure that is not part of\r<br> normal medical care\r<br>\r<br> - Subject has refused any treatment already available for clinically isolated syndrome\r<br> (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial\r<br> Treatment Period of this study\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Subject has a diagnosis of MS (per McDonald criteria, 2005)\r<br>\r<br> - Subject has any other disease that could better explain the subject's signs and\r<br> symptoms\r<br>\r<br> - Subject has complete transverse myelitis or bilateral optic neuritis\r<br>\r<br> - Subject using or has used any other approved MS disease modifying drug (DMD)\r<br>\r<br> - Subject has used any investigational drug or undergone an experimental procedure\r<br> within 12 weeks prior to Study day 1\r<br>\r<br> - Subject received oral or systemic corticosteroids or adrenocorticotropic hormone\r<br> (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days\r<br> after the oral or systemic corticosteroids or ACTH treatment. In case this interfered\r<br> with MRI timing the screening period could be extended accordingly.\r<br>\r<br> - Subject has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine\r<br> aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit\r<br> of normal\r<br>\r<br> - Subject suffered from current autoimmune disease other than MS\r<br>\r<br> - Subject suffered from psychiatric illness (including history of, or concurrent, severe\r<br> depressive disorders and/or suicidal ideation) that in the opinion of the investigator\r<br> creates undue risk to the subject or could affect compliance with the study protocol\r<br>\r<br> - Subject suffered from major medical illness such as cardiac (for example angina,\r<br> congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic,\r<br> metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease\r<br> that would preclude the administration of oral cladribine\r<br>\r<br> - Subject has a history of seizures not adequately controlled by medications\r<br>\r<br> - Subject has a known allergy to cladribine, interferon-beta, the excipient(s) of the\r<br> study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA)\r<br>\r<br> - Subject has any renal condition that would preclude the administration of gadolinium\r<br> (for example acute or chronic severe renal insufficiency (glomerular filtration rate\r<br> [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2])\r<br>\r<br> - Subject has a history of chronic or clinically significant hematological abnormalities\r<br>\r<br> - Subject has a history of active or chronic infectious disease or any disease that\r<br> compromises immune function (for example human immunodeficiency virus positive [HIV+],\r<br> human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection\r<br> [LTBI] or TB, insulin-dependent diabetes).\r<br>\r<br> - Subject has previously been screened in this study (signed an informed consent) and\r<br> then withdrawn\r<br>\r<br> - Subject has received any immunomodulatory or immunosuppressive therapy) at any time\r<br> prior to Study Day 1, including, but not limited to, the following products: any\r<br> interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine,\r<br> methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod,\r<br> cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment\r<br> (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4\r<br> [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy\r<br>\r<br> - Subject has received experimental MS treatment\r<br>\r<br> - Subject has a history of alcohol or drug abuse\r<br>\r<br> - Subject has intolerance or any contraindication to both paracetamol (acetaminophen)\r<br> and ibuprofen\r<br>\r<br> - Subject has inability to administer subcutaneous injections either by self or by\r<br> caregiver\r<br>\r<br> - Subject has prior or current malignancy (with the exception of in situ basal or\r<br> squamous cell skin cancer surgically removed without recurrence for at least five\r<br> years)\r<br>\r<br> - Subject has a positive stool hemoccult test at Screening\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Male or female between 18 and 55 years old, inclusive\r<br>\r<br> - Weighed between 40 to 120 kilogram (kg), inclusive\r<br>\r<br> - Subject has experienced a single, first clinical event suggestive of MS within 75 days\r<br> prior to the Screening visit, (clock starts 24 hours after onset). The event must be a\r<br> new neurological abnormality present for at least 24 hours, either mono- or\r<br> polysymptomatic\r<br>\r<br> - Subject has at least two clinically silent lesions on the T2-weighted MRI scan, at\r<br> screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid\r<br> or periventricular or infratentorial on screening MRI\r<br>\r<br> - Subject has EDSS 0 - 5.0 at Screening\r<br>\r<br> - Subject has no medical history or evidence of latent tuberculosis infection (LTBI) or\r<br> active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or\r<br> a comparable sensitive test according to local regulations/guidelines (if the Mantoux\r<br> test is not available), and/or a chest X-ray\r<br>\r<br> - Subject has normal hematological parameters at Screening, as defined by the central\r<br> laboratory that performed all the assessments\r<br>\r<br> - If female, she must:\r<br>\r<br> - be neither pregnant nor breast-feeding, nor attempting to conceive and\r<br>\r<br> - use a highly effective method of contraception throughout the entire duration of\r<br> the study and for 90 days following completion of the last dose of study\r<br> medication. A highly effective method of contraception is defined as those which\r<br> result in a low failure rate (that is less than 1 percent per year) when used\r<br> consistently and correctly such as implants, injectables, combined oral\r<br> contraceptives, some intrauterine devices, sexual abstinence or vasectomized\r<br> partner, or\r<br>\r<br> - be post-menopausal or surgically sterilized (Note: for Danish sites only,\r<br> subjects should use a hormonal contraceptive or intrauterine device for the\r<br> duration of the trial)\r<br>\r<br> - Male subjects must be willing to use contraception to avoid impregnating partners\r<br> throughout the study, and for 90 days following the last dose of study medication\r<br>\r<br> - Be willing and able to comply with study procedures for the duration of the study\r<br>\r<br> - Subject has to provide written informed consent voluntarily, including, for United\r<br> states of America (USA), subject authorization under Health Insurance Portability and\r<br> Accountability Act (HIPAA), prior to any study-related procedure that is not part of\r<br> normal medical care\r<br>\r<br> - Subject has refused any treatment already available for clinically isolated syndrome\r<br> (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial\r<br> Treatment Period of this study\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Subject has a diagnosis of MS (per McDonald criteria, 2005)\r<br>\r<br> - Subject has any other disease that could better explain the subject's signs and\r<br> symptoms\r<br>\r<br> - Subject has complete transverse myelitis or bilateral optic neuritis\r<br>\r<br> - Subject using or has used any other approved MS disease modifying drug (DMD)\r<br>\r<br> - Subject has used any investigational drug or undergone an experimental procedure\r<br> within 12 weeks prior to Study day 1\r<br>\r<br> - Subject received oral or systemic corticosteroids or adrenocorticotropic hormone\r<br> (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days\r<br> after the oral or systemic corticosteroids or ACTH treatment. In case this interfered\r<br> with MRI timing the screening period could be extended accordingly.\r<br>\r<br> - Subject has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine\r<br> aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit\r<br> of normal\r<br>\r<br> - Subject suffered from current autoimmune disease other than MS\r<br>\r<br> - Subject suffered from psychiatric illness (including history of, or concurrent, severe\r<br> depressive disorders and/or suicidal ideation) that in the opinion of the investigator\r<br> creates undue risk to the subject or could affect compliance with the study protocol\r<br>\r<br> - Subject suffered from major medical illness such as cardiac (for example angina,\r<br> congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic,\r<br> metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease\r<br> that would preclude the administration of oral cladribine\r<br>\r<br> - Subject has a history of seizures not adequately controlled by medications\r<br>\r<br> - Subject has a known allergy to cladribine, interferon-beta, the excipient(s) of the\r<br> study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA)\r<br>\r<br> - Subject has any renal condition that would preclude the administration of gadolinium\r<br> (for example acute or chronic severe renal insufficiency (glomerular filtration rate\r<br> [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2])\r<br>\r<br> - Subject has a history of chronic or clinically significant hematological abnormalities\r<br>\r<br> - Subject has a history of active or chronic infectious disease or any disease that\r<br> compromises immune function (for example human immunodeficiency virus positive [HIV+],\r<br> human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection\r<br> [LTBI] or TB, insulin-dependent diabetes).\r<br>\r<br> - Subject has previously been screened in this study (signed an informed consent) and\r<br> then withdrawn\r<br>\r<br> - Subject has received any immunomodulatory or immunosuppressive therapy) at any time\r<br> prior to Study Day 1, including, but not limited to, the following products: any\r<br> interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine,\r<br> methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod,\r<br> cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment\r<br> (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4\r<br> [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy\r<br>\r<br> - Subject has received experimental MS treatment\r<br>\r<br> - Subject has a history of alcohol or drug abuse\r<br>\r<br> - Subject has intolerance or any contraindication to both paracetamol (acetaminophen)\r<br> and ibuprofen\r<br>\r<br> - Subject has inability to administer subcutaneous injections either by self or by\r<br> caregiver\r<br>\r<br> - Subject has prior or current malignancy (with the exception of in situ basal or\r<br> squamous cell skin cancer surgically removed without recurrence for at least five\r<br> years)\r<br>\r<br> - Subject has a positive stool hemoccult test at Screening\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Male or female between 18 and 55 years old, inclusive\r<br>\r<br> - Weighed between 40 to 120 kilogram (kg), inclusive\r<br>\r<br> - Subject has experienced a single, first clinical event suggestive of MS within 75 days\r<br> prior to the Screening visit, (clock starts 24 hours after onset). The event must be a\r<br> new neurological abnormality present for at least 24 hours, either mono- or\r<br> polysymptomatic\r<br>\r<br> - Subject has at least two clinically silent lesions on the T2-weighted MRI scan, at\r<br> screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid\r<br> or periventricular or infratentorial on screening MRI\r<br>\r<br> - Subject has EDSS 0 - 5.0 at Screening\r<br>\r<br> - Subject has no medical history or evidence of latent tuberculosis infection (LTBI) or\r<br> active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or\r<br> a comparable sensitive test according to local regulations/guidelines (if the Mantoux\r<br> test is not available), and/or a chest X-ray\r<br>\r<br> - Subject has normal hematological parameters at Screening, as defined by the central\r<br> laboratory that performed all the assessments\r<br>\r<br> - If female, she must:\r<br>\r<br> - be neither pregnant nor breast-feeding, nor attempting to conceive and\r<br>\r<br> - use a highly effective method of contraception throughout the entire duration of\r<br> the study and for 90 days following completion of the last dose of study\r<br> medication. A highly effective method of contraception is defined as those which\r<br> result in a low failure rate (that is less than 1 percent per year) when used\r<br> consistently and correctly such as implants, injectables, combined oral\r<br> contraceptives, some intrauterine devices, sexual abstinence or vasectomized\r<br> partner, or\r<br>\r<br> - be post-menopausal or surgically sterilized (Note: for Danish sites only,\r<br> subjects should use a hormonal contraceptive or intrauterine device for the\r<br> duration of the trial)\r<br>\r<br> - Male subjects must be willing to use contraception to avoid impregnating partners\r<br> throughout the study, and for 90 days following the last dose of study medication\r<br>\r<br> - Be willing and able to comply with study procedures for the duration of the study\r<br>\r<br> - Subject has to provide written informed consent voluntarily, including, for United\r<br> states of America (USA), subject authorization under Health Insurance Portability and\r<br> Accountability Act (HIPAA), prior to any study-related procedure that is not part of\r<br> normal medical care\r<br>\r<br> - Subject has refused any treatment already available for clinically isolated syndrome\r<br> (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial\r<br> Treatment Period of this study\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Subject has a diagnosis of MS (per McDonald criteria, 2005)\r<br>\r<br> - Subject has any other disease that could better explain the subject's signs and\r<br> symptoms\r<br>\r<br> - Subject has complete transverse myelitis or bilateral optic neuritis\r<br>\r<br> - Subject using or has used any other approved MS disease modifying drug (DMD)\r<br>\r<br> - Subject has used any investigational drug or undergone an experimental procedure\r<br> within 12 weeks prior to Study day 1\r<br>\r<br> - Subject received oral or systemic corticosteroids or adrenocorticotropic hormone\r<br> (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days\r<br> after the oral or systemic corticosteroids or ACTH treatment. In case this interfered\r<br> with MRI timing the screening period could be extended accordingly.\r<br>\r<br> - Subject has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine\r<br> aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit\r<br> of normal\r<br>\r<br> - Subject suffered from current autoimmune disease other than MS\r<br>\r<br> - Subject suffered from psychiatric illness (including history of, or concurrent, severe\r<br> depressive disorders and/or suicidal ideation) that in the opinion of the investigator\r<br> creates undue risk to the subject or could affect compliance with the study protocol\r<br>\r<br> - Subject suffered from major medical illness such as cardiac (for example angina,\r<br> congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic,\r<br> metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease\r<br> that would preclude the administration of oral cladribine\r<br>\r<br> - Subject has a history of seizures not adequately controlled by medications\r<br>\r<br> - Subject has a known allergy to cladribine, interferon-beta, the excipient(s) of the\r<br> study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA)\r<br>\r<br> - Subject has any renal condition that would preclude the administration of gadolinium\r<br> (for example acute or chronic severe renal insufficiency (glomerular filtration rate\r<br> [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2])\r<br>\r<br> - Subject has a history of chronic or clinically significant hematological abnormalities\r<br>\r<br> - Subject has a history of active or chronic infectious disease or any disease that\r<br> compromises immune function (for example human immunodeficiency virus positive [HIV+],\r<br> human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection\r<br> [LTBI] or TB, insulin-dependent diabetes).\r<br>\r<br> - Subject has previously been screened in this study (signed an informed consent) and\r<br> then withdrawn\r<br>\r<br> - Subject has received any immunomodulatory or immunosuppressive therapy) at any time\r<br> prior to Study Day 1, including, but not limited to, the following products: any\r<br> interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine,\r<br> methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod,\r<br> cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment\r<br> (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4\r<br> [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy\r<br>\r<br> - Subject has received experimental MS treatment\r<br>\r<br> - Subject has a history of alcohol or drug abuse\r<br>\r<br> - Subject has intolerance or any contraindication to both paracetamol (acetaminophen)\r<br> and ibuprofen\r<br>\r<br> - Subject has inability to administer subcutaneous injections either by self or by\r<br> caregiver\r<br>\r<br> - Subject has prior or current malignancy (with the exception of in situ basal or\r<br> squamous cell skin cancer surgically removed without recurrence for at least five\r<br> years)\r<br>\r<br> - Subject has a positive stool hemoccult test at Screening\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Drug: Cladribine;Drug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF);Drug: Cladribine;Drug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF);Drug: Cladribine;Drug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF);Drug: Cladribine;Drug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF)", "primary_outcome": "Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS;Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS;Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS", "secondary_outcome": "Time to Develop Multiple Sclerosis (MS) Conversion According to the Revised McDonald Criteria (2005) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With McDonald MS;Number of Combined Unique Active (CUA) Lesions, New or Enlarging Time Constant 2 (T2) Lesions, and New or Persisting Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan;Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)", "secondary_id": "28821", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3630, "title": "12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.", "summary": null, "published_date": "2008-12-08T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.622725Z", "link": "https://clinicaltrials.gov/show/NCT00735007", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00735007" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "6491118", "last_refreshed_on": "2017-10-19", "scientific_title": "International, Multicenter, Single-arm, Open-label, 12-week Phase IIIb Study to Evaluate RebiSmart™ Suitability for Self Injection of Rebif® New Formulation (RNF) in Multidose Cartridges in Patients With Relapsing Form of Multiple Sclerosis (RMS)", "primary_sponsor": "EMD Serono", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2008-07-15", "target_size": "106", "study_type": "Interventional", "study_design": null, "phase": "Phase 3", "countries": "United States;Canada;Germany;Italy;Spain;Sweden;Canada;Germany;Italy;Spain;Sweden;United States;United States;Canada;Germany;Italy;Spain;Sweden;Canada;Germany;Italy;Spain;Sweden;United States;United States;Canada;Germany;Italy;Spain;Sweden;Canada;Germany;Italy;Spain;Sweden;United States;United States;Canada;Germany;Italy;Spain;Sweden;Canada;Germany;Italy;Spain;Sweden;United States", "contact_firstname": "; ; ;", "contact_lastname": "Elisabetta Verdun di Cantogno, MD;Elisabetta Verdun di Cantogno, MD;Elisabetta Verdun di Cantogno, MD;Elisabetta Verdun di Cantogno, MD", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany;Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany;Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany;Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Males and females between 18 and 65 years of age, inclusive\r<br>\r<br> - Female subjects must be neither pregnant nor breast-feeding and must lack\r<br> child-bearing potential, as defined by either:\r<br>\r<br> - Post-menopausal or surgically sterile, or\r<br>\r<br> - Using a highly effective method of contraception for the duration of the study.\r<br> This is defined as a method that result in a low failure rate (i.e., less than 1%\r<br> per year) when used consistently and correctly, and includes for instance\r<br> implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s,\r<br> sexual abstinence or vasectomised partner.\r<br>\r<br> - Have RMS according to the revised McDonald Criteria 2005\r<br>\r<br> - Have disease duration for at least 3 months\r<br>\r<br> - Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been\r<br> consistently on therapy for a minimum of 6 weeks prior to Screening\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Have any disease other than MS that could better explain his/her signs and symptoms\r<br>\r<br> - Receive any other injectable medications on a regular basis during the week prior to\r<br> the screening period or throughout the duration of the study. The administration of a\r<br> single injection for treatment or prophylaxis of a condition unrelated to the\r<br> patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus\r<br> vaccination) will be acceptable\r<br>\r<br> - Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug\r<br> [DMD]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12\r<br> months prior to study enrolment or at any time during the study\r<br>\r<br> - Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within\r<br> 30 days prior to SD1\r<br>\r<br> - Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x\r<br> upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2\r<br> x ULN if associated with any elevation of ALT or alkaline phosphatase\r<br>\r<br> - Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5\r<br> x lower limit of normal\r<br>\r<br> - Have moderate to severe renal impairment\r<br>\r<br> - History of any chronic pain syndrome\r<br>\r<br> - Any visual or physical impairment that precludes the subject self-injecting the\r<br> treatment using the RebiSmartä\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Males and females between 18 and 65 years of age, inclusive\r<br>\r<br> - Female subjects must be neither pregnant nor breast-feeding and must lack\r<br> child-bearing potential, as defined by either:\r<br>\r<br> - Post-menopausal or surgically sterile, or\r<br>\r<br> - Using a highly effective method of contraception for the duration of the study.\r<br> This is defined as a method that result in a low failure rate (i.e., less than 1%\r<br> per year) when used consistently and correctly, and includes for instance\r<br> implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s,\r<br> sexual abstinence or vasectomised partner.\r<br>\r<br> - Have RMS according to the revised McDonald Criteria 2005\r<br>\r<br> - Have disease duration for at least 3 months\r<br>\r<br> - Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been\r<br> consistently on therapy for a minimum of 6 weeks prior to Screening\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Have any disease other than MS that could better explain his/her signs and symptoms\r<br>\r<br> - Receive any other injectable medications on a regular basis during the week prior to\r<br> the screening period or throughout the duration of the study. The administration of a\r<br> single injection for treatment or prophylaxis of a condition unrelated to the\r<br> patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus\r<br> vaccination) will be acceptable\r<br>\r<br> - Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug\r<br> [DMD]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12\r<br> months prior to study enrolment or at any time during the study\r<br>\r<br> - Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within\r<br> 30 days prior to SD1\r<br>\r<br> - Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x\r<br> upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2\r<br> x ULN if associated with any elevation of ALT or alkaline phosphatase\r<br>\r<br> - Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5\r<br> x lower limit of normal\r<br>\r<br> - Have moderate to severe renal impairment\r<br>\r<br> - History of any chronic pain syndrome\r<br>\r<br> - Any visual or physical impairment that precludes the subject self-injecting the\r<br> treatment using the RebiSmartä\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Males and females between 18 and 65 years of age, inclusive\r<br>\r<br> - Female subjects must be neither pregnant nor breast-feeding and must lack\r<br> child-bearing potential, as defined by either:\r<br>\r<br> - Post-menopausal or surgically sterile, or\r<br>\r<br> - Using a highly effective method of contraception for the duration of the study.\r<br> This is defined as a method that result in a low failure rate (i.e., less than 1%\r<br> per year) when used consistently and correctly, and includes for instance\r<br> implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s,\r<br> sexual abstinence or vasectomised partner.\r<br>\r<br> - Have RMS according to the revised McDonald Criteria 2005\r<br>\r<br> - Have disease duration for at least 3 months\r<br>\r<br> - Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been\r<br> consistently on therapy for a minimum of 6 weeks prior to Screening\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Have any disease other than MS that could better explain his/her signs and symptoms\r<br>\r<br> - Receive any other injectable medications on a regular basis during the week prior to\r<br> the screening period or throughout the duration of the study. The administration of a\r<br> single injection for treatment or prophylaxis of a condition unrelated to the\r<br> patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus\r<br> vaccination) will be acceptable\r<br>\r<br> - Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug\r<br> [DMD]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12\r<br> months prior to study enrolment or at any time during the study\r<br>\r<br> - Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within\r<br> 30 days prior to SD1\r<br>\r<br> - Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x\r<br> upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2\r<br> x ULN if associated with any elevation of ALT or alkaline phosphatase\r<br>\r<br> - Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5\r<br> x lower limit of normal\r<br>\r<br> - Have moderate to severe renal impairment\r<br>\r<br> - History of any chronic pain syndrome\r<br>\r<br> - Any visual or physical impairment that precludes the subject self-injecting the\r<br> treatment using the RebiSmartä\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Males and females between 18 and 65 years of age, inclusive\r<br>\r<br> - Female subjects must be neither pregnant nor breast-feeding and must lack\r<br> child-bearing potential, as defined by either:\r<br>\r<br> - Post-menopausal or surgically sterile, or\r<br>\r<br> - Using a highly effective method of contraception for the duration of the study.\r<br> This is defined as a method that result in a low failure rate (i.e., less than 1%\r<br> per year) when used consistently and correctly, and includes for instance\r<br> implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s,\r<br> sexual abstinence or vasectomised partner.\r<br>\r<br> - Have RMS according to the revised McDonald Criteria 2005\r<br>\r<br> - Have disease duration for at least 3 months\r<br>\r<br> - Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been\r<br> consistently on therapy for a minimum of 6 weeks prior to Screening\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Have any disease other than MS that could better explain his/her signs and symptoms\r<br>\r<br> - Receive any other injectable medications on a regular basis during the week prior to\r<br> the screening period or throughout the duration of the study. The administration of a\r<br> single injection for treatment or prophylaxis of a condition unrelated to the\r<br> patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus\r<br> vaccination) will be acceptable\r<br>\r<br> - Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug\r<br> [DMD]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12\r<br> months prior to study enrolment or at any time during the study\r<br>\r<br> - Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within\r<br> 30 days prior to SD1\r<br>\r<br> - Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x\r<br> upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2\r<br> x ULN if associated with any elevation of ALT or alkaline phosphatase\r<br>\r<br> - Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5\r<br> x lower limit of normal\r<br>\r<br> - Have moderate to severe renal impairment\r<br>\r<br> - History of any chronic pain syndrome\r<br>\r<br> - Any visual or physical impairment that precludes the subject self-injecting the\r<br> treatment using the RebiSmartä\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Drug: Rebif® New Formulation (RNF) using RebiSmartTM;Drug: Rebif® New Formulation (RNF) using RebiSmartTM;Drug: Rebif® New Formulation (RNF) using RebiSmartTM;Drug: Rebif® New Formulation (RNF) using RebiSmartTM", "primary_outcome": "The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).;The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).", "secondary_outcome": "Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12;The Incidence of Predefined Injection Site Reactions, MSTCQ Scores, Side Effects, McGill Pain Questionnaire, Visual Analog Scale, and Rating of Pain Regarding Injection Pain Following RNF Administration With RebiSmart at 12-week Treatment Period.", "secondary_id": "28733", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3629, "title": "The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple Sclerosis\nA double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trial", "summary": null, "published_date": "2008-08-18T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.596379Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007759-15", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2007-007759-15-HU" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "2471913", "last_refreshed_on": "2012-03-19", "scientific_title": "The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple Sclerosis\nA double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trial", "primary_sponsor": "PEPTIMMUNE Inc", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2008-10-11", "target_size": "53", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes\nRandomised: yes\nOpen: yes\nSingle blind: no\nDouble blind: yes\nParallel group: no\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no", "phase": null, "countries": "Hungary", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>1. Male or female subjects between the ages of 18 and 60 (inclusive) who have signed an approved, informed consent document.<br>2. Patients must have a current diagnosis of SP-MS with duration of diagnosis of at least 1 year and less than 10 years from the baseline examination.<br>3. Female subjects must not be pregnant or lactating. If of childbearing potential, subjects must decide in conjunction with their physician on a double contraceptive method that they will use in order to avoid being pregnant since at least 14 days before their entry in the study as well as throughout the duration of the study.<br> 4. If a female subject is unable to bear children, this must be documented on the Case Report Form (CRF; e.g., tubal ligation, hysterectomy, postmenopausal). Postmenopausal is defined as a minimum of 1 year since the last menstrual period.<br>5. Subject must have evidence of MS obtained by MRI (T1 weighted imaging with gadolinium contrast) using a 1.5 Tesla magnet within 1 year of the baseline examination with =10 active gadolinium enhancing lesions).<br>6. EDSS of = 3 and <7.<br>7. Subjects must be willing and able to comply with the protocol requirements.<br>8. With the exception of signs and symptoms that directly relate to their MS, subjects must be in good general health, without significant medical history, physical examination findings, or clinically-significant abnormal laboratory results.<br>9. Subjects must have a negative alcohol breathalyzer test and a urine screen for drugs of abuse at the Screening Visit.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>1. Currently or within the past 5 years, history of malignancy other than squamous or basal cell carcinoma of the skin.<br>2. A current diagnosis or recent history within 2 years of alcoholism; drug abuse; or severe emotional, behavioral, or psychiatric problems that would hinder adequate compliance with study requirements.<br>3. History of clinically significant gastrointestinal, renal, hepatic, endocrinic, oncologic, pulmonary or cardiovascular disease; or a history of tuberculosis, epilepsy, diabetes, psychosis, glaucoma; or any other condition, which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.<br>4 Clinically significant abnormality on screening or baseline ECG (allowable abnormalities: occasional premature atrial beats, abnormal PR interval not associated w/ SVT or heart block, RBBB, resting ST =100 or SB = 50).<br>5. A positive pregnancy test at the Screening Visit (serum test) or Day 1, prior to drug administration (urine test).<br>6. MRI at Screening showing >10 CNS gadolinium-enhancing lesions on T1 scans consistent with Multiple Sclerosis, using a 1.5 Tesla magnet.<br>7. Any relapse of multiple sclerosis within the prior 3 months.<br>8. Immunosuppression due to acquired immunodeficiency syndrome (AIDS), or cancer chemotherapy within the 6 months prior to the Screening Visit, or other etiology of immunosuppression.<br>9. History or evidence of hepatitis B or C.<br>10. Participation in a previous investigational drug or device study within 30 days preceding the Screening Visit.<br>11. History of any prior Copaxone®, Cellcept, Tysabri, or Campath use.<br>12. History of total lymphoid irradiation.<br>13. History within the prior 3 months prior to the Screening Visit of glucocorticoid therapy.<br>14. History within the prior 6 months prior to the Screening Visit of any of the following: azathioprine, cladribine, cyclophosphamide, cyclosporine, interferon beta-1a or interferon beta-1b, methotrexate, or mitoxantrone.<br><br>", "condition": "Patients with current diagnosis of SP-MS <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10063400\nTerm: Secondary progressive multiple sclerosis", "intervention": "<br>Product Name: PI-2301<br>Product Code: CO-14<br>Pharmaceutical Form: Solution for injection<br>CAS Number: 1026791-33-1<br>Current Sponsor code: PI-2301<br>Other descriptive name: CO-14<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 20-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Subcutaneous use<br><br>", "primary_outcome": "Main Objective: The primary objective of this study is to evaluate the safety and tolerability of 4 to 6 dose levels of PI 2301 in subjects with SP-MS when administered weekly for up to 12 weeks;Secondary Objective: The secondary objectives of this study are to evaluate the pharmacokinetics, effects on immunological/biological markers, magnetic resonance imaging (MRI), and the Expanded Disability Status Scale (EDSS) of 4 to 6 dose levels of PI-2301 in subjects with SP-MS when administered weekly for up to 12 weeks;Primary end point(s): Safety parameters : <br>Safety will be monitored with using physical examinations, vital signs, ECGs, laboratory testing, and AE/SAE assessments. Particular attention will be focused on monitoring for anaphylaxis or hypersensitivity reactions, systemic inflammatory response syndrome (SIRS), and injection site reaction (ISR). <br>", "secondary_outcome": null, "secondary_id": "CO-200-102", "source_support": null, "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3628, "title": "SUPREMES - Sunphenon in progressive forms of multiple sclerosis", "summary": null, "published_date": "2008-08-22T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.575120Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005213-22", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-005213-22-DE" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "8972348", "last_refreshed_on": "2020-03-18", "scientific_title": "SUPREMES - Sunphenon in progressive forms of multiple sclerosis - SUPREMES", "primary_sponsor": "Charite Universitätsmedizin Berlin", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": null, "target_size": "60", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: yes\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no\nNumber of treatment arms in the trial: 2", "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): yes\nTherapeutic confirmatory - (Phase III): yes\nTherapeutic use (Phase IV): no", "countries": "Germany", "contact_firstname": "NeuroCure Clinical Research Center", "contact_lastname": null, "contact_address": "Chariteplatz 1", "contact_email": "[email protected]", "contact_tel": "004930450 539 728", "contact_affiliation": "Charite Universitätsmedizin Berlin", "inclusion_criteria": "Inclusion criteria: <br>age 18-65, primary or secondary progressive Multiple Sclerosis according to McDonald-criteria, EDSS 3-8, negative pregnancy test, use of highly effective methods of birth control in women with childbearing potential, informed consent, max. 4 cups of coffee and 2 cups of black tea daily, no consumption of grean tea or larger amounts of grapefruit juice, at least 30 days between the last relapse and screening\r<br>\r<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 52<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 8<br>", "exclusion_criteria": "Exclusion criteria: <br>relapsing remitting Multiple Sclerosis, clinical or laboratory findings of impaired liver function, psychiatric disorders, concomitant medication of hepatotoxic medication, any other relevant disorder<br>", "condition": "primary and secondary progressive forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]", "intervention": "<br>Product Name: Sunphenon<br>Pharmaceutical Form: Capsule, hard<br>Other descriptive name: Sunphenon EGCg<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: To evaluate efficacy and safety of Sunphenon EGCg in progressive forms of multiple sclerosis after a 36 months treatment compared to the placebo-group, primary outcome criteria being reduction of Brain Parenchymal Fraction (atrophy) ;Secondary Objective: - T2-lesions (number and volume)<br>- T1 hypointensive lesions („black holes“)<br>- changes in the NAA/Cr ratio (spectroscopy)<br>- EDSS<br>- cognitive functions and fatigue <br>- RNFL („retinal nerve fiber layer“) thickness (optic coherencetomography)<br><br>;Primary end point(s): Brain Parenchymal Fraction / atrophy after 36 months of treatment vs. placebo;Timepoint(s) of evaluation of this end point: month 0-36<br>", "secondary_outcome": "Secondary end point(s): T2 leasion, T1 hypotensive leasion, EDSS, changes in NAA/Cr quotient in spectroscopy, cognitive disorders and fatigue\r<br>RNFL thickness in OCT;Timepoint(s) of evaluation of this end point: month 0-36\r<br>", "secondary_id": "SUPREMES-01", "source_support": null, "ethics_review_status": "Approved", "ethics_review_approval_date": "1900-01-01", "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3627, "title": "A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State", "summary": null, "published_date": "2008-08-29T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.554370Z", "link": "http://clinicaltrials.gov/show/NCT00744679", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00744679" }, "categories": [ { "category_id": 7, "category_description": "", "category_name": "Natalizumab", "category_slug": "natalizumab", "category_terms": [ "natalizumab", "tysabri" ], "article_count": 298 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "4646491", "last_refreshed_on": "2015-02-19", "scientific_title": "An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions", "primary_sponsor": "Biogen Idec", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "Both", "date_enrollement": "2008-11-15", "target_size": "20", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science", "phase": "Phase 4", "countries": "United States", "contact_firstname": "", "contact_lastname": "Medical Director", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Biogen Idec", "inclusion_criteria": "<br> Key Inclusion Criteria:\r<br>\r<br> - Ability to understand the purpose and risks of the study and provide signed and dated\r<br> informed consent and authorization to use protected health information (PHI) in\r<br> accordance with national and local subject privacy regulations.\r<br>\r<br> - Must be a multiple sclerosis (MS) patient enrolled in the Tysabri Outreach: United\r<br> Commitment to Health Prescribing Program (TOUCH) who is not expected to discontinue\r<br> Tysabri therapy prior to completion of the requirements of this study.\r<br>\r<br> - Must have been treated with monthly IV infusions of Tysabri 300 mg for at least 12\r<br> months, with the 9 most recent doses having been administered at 28±7 day intervals.\r<br>\r<br> - Must test negative for antibodies to Tysabri at the Screening Visit.\r<br>\r<br> - Must have a magnetic resonance imaging (MRI) brain scan, performed prior to the\r<br> initiation of treatment with Tysabri, on file.\r<br>\r<br> - Must weigh between 42 and 126 kg, inclusive.\r<br>\r<br> - All male subjects and female subjects of childbearing potential must practice\r<br> effective contraception during the study.\r<br>\r<br> Key Exclusion Criteria:\r<br>\r<br> - History of, or abnormal laboratory results indicative of, any clinically significant\r<br> cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic,\r<br> pulmonary, gastrointestinal, dermatologic, psychiatric, and renal, or other major\r<br> disease, as determined by the Investigator.\r<br>\r<br> - Positive result for antibodies to Tysabri at any prior evaluation.\r<br>\r<br> - Treatment with an investigational product or approved therapy for investigational use\r<br> within 6 months prior to the start of PK sample collection or during the course of\r<br> this study. Concurrent participation in an observational study (e.g., Tysabri Global\r<br> Observational Program in Safety [TYGRIS]) is permitted.\r<br>\r<br> - Pre-scheduled for any elective procedure or medical treatment during the study\r<br> period.\r<br>\r<br> - History of drug or alcohol abuse (as defined by the Investigator) within 2 years\r<br> prior to the Screening Visit.\r<br>\r<br> - Female subjects who are breastfeeding, pregnant, or planning to become pregnant while\r<br> on study.\r<br>\r<br> - Alcohol use within 24 hours prior to the Baseline Visit.\r<br>\r<br> - Inability or unwillingness to comply with study requirements, including the presence\r<br> of any condition (e.g., physical, mental, social) that is likely to affect the\r<br> subject's ability to comply with the study protocol.\r<br>\r<br> - Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec,\r<br> make the subject unsuitable for enrollment.\r<br>\r<br> NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: Natalizumab", "primary_outcome": "Pharmacokinetic (PK) Profile of Natalizumab", "secondary_outcome": "Natalizumab Binding Saturation Of a4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC).", "secondary_id": "101MS406", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3626, "title": "An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease", "summary": null, "published_date": "2008-02-09T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.533298Z", "link": "https://clinicaltrials.gov/show/NCT00745615", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00745615" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "10205856", "last_refreshed_on": "2020-12-12", "scientific_title": "An Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL)", "primary_sponsor": "Teva Pharmaceutical Industries, Ltd.", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "50 Years", "inclusion_gender": "All", "date_enrollement": "2005-12-07", "target_size": "257", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).", "phase": "Phase 2", "countries": "Czechia;Germany;Hungary;Israel;Italy;Poland;Russian Federation;Spain;United Kingdom;Czechia;Germany;Hungary;Israel;Italy;Poland;Russian Federation;Spain;United Kingdom;Czech Republic", "contact_firstname": "", "contact_lastname": "Giancarlo Comi", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy", "inclusion_criteria": "<br> Inclusion Criteria - Participants must have completed the 36 weeks of treatment (completion\r<br> of the full 36 weeks or as requested by the Sponsor) of the active double-blind phase. -\r<br> Women of childbearing potential (for example, women who were not postmenopausal or\r<br> surgically sterilized) must have practiced 2 acceptable methods of birth control for the\r<br> duration of the study and until 30 days after the last dose of study medication (acceptable\r<br> methods of birth control in this open-label extension phase included intrauterine devices,\r<br> barrier methods [condom or diaphragm with spermicide], and hormonal methods of birth\r<br> control [for example, oral contraceptive, contraceptive patch, and long-acting injectable\r<br> contraceptive]). - Participants must have been willing and able to comply with the protocol\r<br> requirements for the duration of LAQ/5063 OL. - Participants must have given signed,\r<br> written informed consent prior to entering LAQ/5063 OL. - For the 36 months further\r<br> extension: Participants must have completed the 24 months of treatment of the first period\r<br> of the open label phase. Exclusion Criteria - For the 36 month further extension: Premature\r<br> discontinuation from LAQ/5063 OL phase prior to completion of 24 months of treatment\r<br> period. - Pregnancy or breastfeeding. - Participants with clinically significant or\r<br> unstable medical or surgical condition, detected or worsened during the active double-blind\r<br> phase of LAQ/5063, which would have precluded safe and complete study participation. - Use\r<br> of experimental drugs, immunosuppressive drugs, and/or participation in clinical studies\r<br> within the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. -\r<br> Previous treatment with immunomodulators with the exception of laquinimod (including\r<br> interferon [IFN] 1a and 1b, glatiramer acetate, and intravenous [IV] immunoglobulin) within\r<br> 2 months prior to entering the open-label phase for those subjects who had a time gap\r<br> between termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of\r<br> corticosteroids within 30 days prior to entering the open-label phase, except for IV\r<br> methylprednisolone 1 grams/day for a maximum of 3 days, in the period from termination of\r<br> LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of potent inhibitors of cytochrome\r<br> P3A4 (CYP3A4) within 2 weeks prior to LAQ/5063 OL and/or use of fluoxetine 1 month prior to\r<br> entering LAQ/5063 OL, in the period from termination of LAQ/5063 active double-blind phase\r<br> to LAQ/5063 OL. - Use of the following substrates of cytochrome P1A2 (CYP1A2): theophylline\r<br> and/or warfarin within 2 weeks prior to entering LAQ/5063 OL, in the period from\r<br> termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of amiodarone in\r<br> the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. -\r<br> Following the switch to new formulation (capsules), hypersensitivity to mannitol,\r<br> meglumine, or sodium stearyl fumarate.\r<br>", "exclusion_criteria": null, "condition": "Relapsing Remitting Multiple Sclerosis", "intervention": "Drug: Laquinimod;Drug: Placebo", "primary_outcome": "Double-Blind Extension Period: Number of Participants With Adverse Events (AEs);Open-label Extension Period: Number of Participants With AEs;Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs;Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs", "secondary_outcome": "Double-Blind Period: Relapse Rate: Total Number of Confirmed Relapses;Double-Blind Period: Percentage of Relapse-Free Participants;Double-Blind Period: Number of Enhancing Lesions on T1-Weighted Images;Double-Blind Period: Number of New T2 Lesions;Double-Blind Period: Volume of T2 Lesions;Double-Blind Period: Number of New Hypointense T1 Lesion on Enhanced T1 Scans;Double-Blind Period: Kurtzke's Expanded Disability Status Scale (EDSS) Score", "secondary_id": "LAQ/5063;2005-004334-41;LAQ/5063OL", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3625, "title": "Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri", "summary": null, "published_date": "2008-11-09T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.515365Z", "link": "http://clinicaltrials.gov/show/NCT00752778", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00752778" }, "categories": [ { "category_id": 7, "category_description": "", "category_name": "Natalizumab", "category_slug": "natalizumab", "category_terms": [ "natalizumab", "tysabri" ], "article_count": 298 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "4647107", "last_refreshed_on": "2015-02-19", "scientific_title": "MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri", "primary_sponsor": "University Hospital, Strasbourg, France", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "Both", "date_enrollement": "2008-12-15", "target_size": "8", "study_type": "Interventional", "study_design": "Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 4", "countries": "France", "contact_firstname": "", "contact_lastname": "Jérôme DE SEZE, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Hôpitaux universitaires de Strasbourg", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Patients diagnosed with MS\r<br>\r<br> - Treatment with Tysabri planned\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Allergy to Tysabri or MRI contrast products\r<br>\r<br> - Pregnancy\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: pet-scan FDG-F18", "primary_outcome": "Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain).", "secondary_outcome": "Correlation with relapses.", "secondary_id": "4118", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3624, "title": "A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS)", "summary": null, "published_date": "2008-09-15T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.495540Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004579-22", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-004579-22-AT" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "2468667", "last_refreshed_on": "2012-03-19", "scientific_title": "A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS)", "primary_sponsor": "Octapharma AG", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Not Recruiting", "other_records": "Yes", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2008-10-14", "target_size": "30", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: no\nRandomised: no\nOpen: no\nSingle blind: no\nDouble blind: no\nParallel group: no\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: no\nOther: no", "phase": null, "countries": "Austria", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>·Subjects aged = 18 years.<br>MS according to the revised McDonald criteria.<br>Relapsing-remitting form of MS.<br>First-line disease modifying treatments (IFN-beta or glatiramer acetate) are contraindicated or not tolerated.<br>Kurtzke’s EDSS between 0 and 3.5 (0 to <= 3.5).<br>Subjects who experienced at least one relapse during the last 12 months or at least two relapses in the last 24 months prior to study entry.<br>Freely given, fully informed written consent obtained from subject.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>Subjects who have received treatment with immunoglobulins for any reason previously.<br>Subjects who have received immuno-suppressive treatments (e.g. azathioprine, mitoxantrone, cyclophosphamide) for any reason previously except relapse treatment with corticosteroids.\t<br>Subjects who have received disease modifying first-line treatments treatment with IFN-beta during the last 8 weeks or with glatiramer acetate during the last 16 weeks.<br>Subjects who have received any monoclonal antibody therapies (e.g. natalizumab) previously.\t<br>Subjects who had a relapse within 3 months prior to study entry.\t<br>Subjects with severe renal function impairment as defined by serum creatinine values > 24 mg/L.\t<br>Subjects with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the subject has antibodies against IgA.<br>Subjects with a body weight of >120 kg.<br>Subjects with a history of anaphylaxis after previous transfusions of blood or blood products.<br>Subjects for whom MRI is contraindicated or who are allergic to gadolinium. Pregnant or lactating women.\t<br>Subjects who delivered a baby within 12 months before study entry (including miscarriage and stillbirth).\t<br>Subjects with a diagnosis of significant depression.\t<br>Subjects with known chronic infectious diseases or malignant disease.·\tSubjects with known antibody deficiencies or other autoimmune diseases other than MS.Subjects participating in another study during the course of this study or during the past 6 months or who have ever participated in a study investigating in new disease modifying or immunosuppressive drugs. <br>", "condition": "Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated.", "intervention": "<br>Trade Name: Octagam 5%<br>Product Name: Octagam 5%<br>Pharmaceutical Form: Intravenous infusion<br>INN or Proposed INN: Immunoglobulin<br>CAS Number: 9007-83-4<br>Concentration unit: % percent<br>Concentration type: equal<br>Concentration number: 5-<br><br>", "primary_outcome": "Secondary Objective: ;Primary end point(s): Heidelberg Assay Panel<br>B-cell Antibody Response Panel<br>Clinical Response: Relapse Activity, Disability Assessment;Main Objective: To investigate whether any parameters of the HAP correlate with the clinical effect observed following Octagam 5% treatment in subjects with RR MS.\t<br>To investigate whether any B-cell/antibody responses correlate with the clinical effect observed following Octagam 5% treatment in subjects with RR MS.\t<br>To investigate the proportion of subjects responding to Octagam 5% treatment vs. subjects not responding.<br>To investigate the relapse activity during the observation period.<br>To investigate efficacy as assessed by neurological examinations using the Expanded Disability Status Scale (EDSS) and Functional System (FS) and the Multiple Sclerosis Functional Composite measure (MSFC).<br>To investigate the change of T2/T1 lesion load and active lesions as demonstrated by contrast enhancement on magnetic resonance imaging (MRI).<br>To investigate the tolerability of Octagam 5% in subjects with RR MS by monitoring safety parameters (vital signs, adverse events (AEs), safety laboratory tests).", "secondary_outcome": null, "secondary_id": "GAM-25", "source_support": null, "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null } ] }