Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=76
{ "count": 4842, "next": "http://api.gregory-ms.com/trials/?format=api&page=77", "previous": "http://api.gregory-ms.com/trials/?format=api&page=75", "results": [ { "trial_id": 3609, "title": "Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis", "summary": null, "published_date": "2008-04-11T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.117996Z", "link": "http://clinicaltrials.gov/show/NCT00785473", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00785473" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "4649587", "last_refreshed_on": "2015-02-19", "scientific_title": "Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study", "primary_sponsor": "University Hospital of North Norway", "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": "Both", "date_enrollement": "2008-01-27", "target_size": "80", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention", "phase": "Phase 4", "countries": "Norway", "contact_firstname": "", "contact_lastname": "Margitta T Kampman, MD, PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "University Hospital of North Norway", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Age 18 to 50 years\r<br>\r<br> - EDSS < 4.0 (able to walk without rest some 500 m)\r<br>\r<br> - Women have to be premenopausal\r<br>\r<br> - MS according to the McDonald criteria; prepared and considered able to follow the\r<br> protocol; using appropriate contraceptive methods (women of childbearing potential)\r<br>\r<br> - Having given written informed consent.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Pregnancy or unwillingness to use contraception; alcohol or drug abuse\r<br>\r<br> - Use of glucocorticoid treatment other than intravenous methylprednisolone for\r<br> treatment of relapses\r<br>\r<br> - Known allergy to cholecalciferol or arachis oil (peanuts)\r<br>\r<br> - Therapy with digitalis, calcitonin, active vitamin D3 analogues, fluoride, or\r<br> bisphosphonates during the previous 12 months\r<br>\r<br> - Any condition predisposing to hypercalcaemia\r<br>\r<br> - Nephrolithiasis or renal insufficiency\r<br>\r<br> - Presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the\r<br> year before the study began; a history of nephrolithiasis during the previous five\r<br> years.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis, Osteoporosis", "intervention": "Dietary Supplement: cholecalciferol;Dietary Supplement: calcium carbonate", "primary_outcome": "Changes in BMD over the 2 year study period comparing treatment and placebo groups", "secondary_outcome": "Cytokine expression following vitamin D supplementation;Contribution of vitamin D from different sources (generation in the skin, diet and supplements) to serum 25(OH) vitamin D (vitamin D status);Changes in parameters of lower extremity function over the 2 year study period;The number of relapses, the time to first relapse, the number of relapse-free patients;The number of patients without progression of disability judged by EDSS and;Reported infections;Ratings on a fatigue scale", "secondary_id": "EudraCT 2006-00427-11;MSvitD1", "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": 3608, "title": "Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment", "summary": null, "published_date": "2008-06-11T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.083371Z", "link": "https://clinicaltrials.gov/show/NCT00787657", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00787657" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "5187294", "last_refreshed_on": "2015-10-26", "scientific_title": "Betaferon Prospective Study on Adherence, Coping and Nursing Support", "primary_sponsor": "Bayer", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "12 Years", "inclusion_agemax": "N/A", "inclusion_gender": "Both", "date_enrollement": "2008-06-27", "target_size": "1723", "study_type": "Observational", "study_design": "Observational Model: Cohort, Time Perspective: Prospective", "phase": "N/A", "countries": "Argentina;Bahrain;Belgium;Bosnia and Herzegovina;Canada;China;Colombia;Czech Republic;Egypt;Estonia;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Kuwait;Lebanon;Libyan Arab Jamahiriya;Mexico;Netherlands;New Zealand;Norway;Pakistan;Portugal;Saudi Arabia;Singapore;Slovakia;Slovenia;Sweden;Syrian Arab Republic;Taiwan;United Arab Emirates;United Kingdom;Venezuela;Argentina;Bahrain;Belgium;Bosnia and Herzegovina;Canada;China;Colombia;Czech Republic;Egypt;Estonia;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Kuwait;Lebanon;Libyan Arab Jamahiriya;Mexico;Netherlands;New Zealand;Norway;Pakistan;Portugal;Saudi Arabia;Singapore;Slovakia;Slovenia;Sweden;Syrian Arab Republic;Taiwan;United Arab Emirates;United Kingdom;Venezuela", "contact_firstname": "", "contact_lastname": "Bayer Study Director", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Bayer", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Patients after first clinical event suggestive of multiple Sclerosis (MS) (according\r<br> to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the\r<br> first two years of diagnosis.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Contra-indications as indicated in Betaferon summary of Products Characteristics\r<br> (SmPC)\r<br>", "exclusion_criteria": null, "condition": "Relapsing Remitting Multiple Sclerosis (RRMS)", "intervention": "Drug: Interferon beta-1b (Betaseron, BAY86-5046)", "primary_outcome": "Proportion of patients adhering to treatment", "secondary_outcome": "Rate of early treatment termination;Rate of study dropout;Predictive value of BL parameters, WCQ, HADS, RODQ;WCQ (Ways of Coping Questionnaire);HADS (Hospital Anxiety and Depression Scale);RODQ (Risk of Dropout Questionnaire);EDSS (Expanded Disability Status Scale);Relapse rate", "secondary_id": "311941;BF0703;13852", "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": 3607, "title": "Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple\n___________________________________________________________________\nA 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis", "summary": null, "published_date": "2008-11-17T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.056383Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001999-67", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-001999-67-ES" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "11471312", "last_refreshed_on": "2021-10-08", "scientific_title": "Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple\n___________________________________________________________________\nA 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis", "primary_sponsor": "sanofi-aventis Recherche & Développement", "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": "2009-01-30", "target_size": "368", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>", "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): yes\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): no", "countries": "France;Finland;Spain;Germany", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>1. Clinically definite MS (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS AND walking disability due to MS (untreated or treated with a stable regimen of a marketed compound for treatment of MS, limited to beta interferons or glatiramer acetate). MS type (relapsing-remitting, secondary progressive, primary progressive, or progressive relapsing) will be determined by the Investigator based on the AAN Practice Guidelines and Tools (http://www.aan.com/go/practice/guidelines) and reference 1 provided in the protocol. <br>2. Signed Informed Consent form<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>Methodology-related<br>1. Patient who is able to walk 25 feet in less than 8 seconds or subject who takes more than 45 seconds (for any of the 2 allowed trials) to walk 25 feet with or without an assistive device during the T25-FW assessment at V1-V4 (before randomization). Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization.<br>2. Multiple sclerosis exacerbation or clinical relapse within 6 months prior to the screening visit (V1) or change in regimen or type of MS treatment during the last 3 months, or start of MS disease-modifying therapies within the 3 months prior to screening.<br>3. Age <18 years<br>4. Patients who participated in any previous nerispirdine (HP184) trials<br>5. Patients who were previously exposed to 3,4-diaminopyridine or 4-aminopyridine (4-AP, fampridine, Fampridine-SR)<br>6. Patients with current active psychiatric disorders including but not limited to active psychosis, exacerbation of schizophrenia, bipolar disorder, obsessive-compulsive disorder, major depressive disorder, anxiety disorder, and alcohol or substance abuse or dependence (except nicotine)<br>7. Use of any investigational drug within 30 days or 5 half-lives whichever is longer<br>8. Patient is the Investigator or any Subinvestigator, Research Assistant, Pharmacist, Study Coordinator, other staff or relative thereof directly involved in the conduct of the protocol/study<br>9. Patients who are unable to participate for the entire duration of the study, or in the opinion of the Investigator, are likely to be non-compliant with the obligations inherent in the clinical trial participation<br>10. Any clinically meaningful or unexplained laboratory abnormality(ies); clinically significant or unstable condition(s) or comorbidities; acute or chronically progressive medical or surgical disorder(s) other than MS which may interfere with walking and may affect patient safety (see Appendix L of the protocol)<br>Patients with confirmed neutropenia (neutrophils < 1500/mm3 or according to ethnic group), thrombocytopenia (platelets < 100 000/ mm3), increase in aminotransferases (either ALT [SGPT] or AST [SGOT] >3 ULN and CPK normal) or creatinine clearance < 50 mL/min cannot be randomized (see Appendix L specifying criteria for discontinuation of IP).<br><br>-Nerispirdine-related based on current knowledge on the compound<br>11. Criteria to reduce reproductive risk:<br>Breastfeeding and pregnant females cannot be included in a clinical study testing nerispirdine. Male subjects who are sexually active with a pregnant female should not participate in the study. Also, patients wishing to breastfeed or parent a child during the course of the study must not participate.<br>Women of childbearing potential (WOCBP) as defined in the protocol or male patients not using an effective contraceptive method as described in the protocol cannot be included in clinical studies testing nerispirdine. Women of childbearing potential, who are unwilling to or unable to be tested for pregnancy at study entry and at each clinic visit, or who experience an unexpected delay of menses cannot participate in the study. The pregnancy test to be used in this study is a serum pregnancy test (?-HCG), and not an urine pregnancy test. This test will be performed at each visit.<br>If, during any nerispirdine study, a female subject becomes pregnant or decides to attempt to become pregnant or if a male subject decides to attempt to father a child, then she or he must stop the study drug immediately. If", "condition": "Esclerosis Múltiple\n______________\nMultiple Sclerosis <br>MedDRA version: 11.0\nLevel: LLT\nClassification code 10028245\nTerm: <Manually entered code. Term in E.1.1>", "intervention": "<br>Product Name: Nerispirdine hydrochloride<br>Product Code: HP184<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: Nerispirdine hydrochloride<br>CAS Number: 119229-64-0<br>Current Sponsor code: HP184<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: The primary objective is to assess the activity of nerispirdine in improving ability to walk, defined as a consistent improvement in walking speed as measured by the Timed 25-Foot Walk (T25-FW) in patients with MS.;Secondary Objective: ?To assess other measures of efficacy such as the MSWS-12, MFIS, LEMMT, MAS, SGI, and CGI<br>?To assess the safety and tolerability of nerispirdine<br>?To evaluate the pharmacokinetic (PK) parameters of nerispirdine and its active metabolite, HP183;Primary end point(s): ? Responder criterion, based on consistency of improved response in walking speed on the T25-FW <br>A responder is defined as one whose last T25-FW measurement on-treatment and at least 2 other T25-FW measurement on-treatment are faster than the fastest speed recorded during any of the 3 ?off drug? visits V2 to V4 before double-blind treatment and the 1 at the end of the 2-week placebo run-out period. All other randomized patients are defined as non-responders.", "secondary_outcome": null, "secondary_id": "DRI10566", "source_support": null, "ethics_review_status": "Approved", "ethics_review_approval_date": "2009-09-01", "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": "2010-02-03", "results_url_link": null }, { "trial_id": 3606, "title": "Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)", "summary": null, "published_date": "2008-11-21T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.019414Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004954-34", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-004954-34-CZ" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "3729272", "last_refreshed_on": "2014-01-27", "scientific_title": "Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION", "primary_sponsor": "Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany", "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": "2008-12-12", "target_size": "492", "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\nOther trial design description: Not applicable\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: no\nOther: yes\nOther specify the comparator: The control group is the “delayed treatment” group - subjects randomized to placebo in study 27025\nNumber of treatment arms in the trial: 2", "phase": null, "countries": "Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany", "contact_firstname": "Communication Center Merck KGaA", "contact_lastname": null, "contact_address": "Frankfurter Strasse 250", "contact_email": "[email protected]", "contact_tel": "+496151 725200", "contact_affiliation": "Merck KGaA", "inclusion_criteria": "Inclusion criteria: <br>All of the following criteria must be met for inclusion of a subject into the trial:\r<br>· Reach scheduled End of Study in study 27025 (completion of 24 months participation),\r<br>· Medical assessment by the Investigator/treating physician from study 27025 that there is no objection to the subject’s participation in this extension trial considering the medical experience from study 27025. Special attention should be given to laboratory abnormalities and clinically significant liver, renal and bone-marrow dysfunction,\r<br>· If female, subject must:\r<br> · be neither pregnant nor breast-feeding, nor attempting to conceive,\r<br> · use a highly effective method of contraception. A highly effective method of contraception is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner,\r<br>· Subject is willing to follow study procedures,\r<br>· Subject has given written informed consent.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 492<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 0<br>", "exclusion_criteria": "Exclusion criteria: <br>Subjects are to be excluded from enrolment into the trial if they fulfill any of the following exclusion criteria:\r<br>· Subject has any disease other than MS that could better explain the subject’s signs and symptoms,\r<br>· Subject has a primary progressive course of MS,\r<br>· Subject has total bilirubin > 2.5 times upper limit of normal at both Month 24 and at the previous visit (i.e. Month 21) (subjects with > 2.5 times upper limit of normal at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalisation of the value),\r<br>· Subject has total aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of normal values at both Month 24 and at the previous visit (i.e. Month 21) (subjects with > 2.5 times upper limit of normal at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalisation of the value),\r<br>· Subject suffers from another current autoimmune disease,\r<br>· Subject suffers from major medical or psychiatric illness (including history of, or current, severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol,\r<br>· Subject has a history of seizures not adequately controlled by treatment,\r<br>· Subject has cardiac disease, such as angina, congestive heart failure or arrhythmia,\r<br>· Subject has a known allergy to IFN-beta or the excipient(s) of the study medication,\r<br>· Subject has any condition that could interfere with the MRI evaluation,\r<br>· Subject has a known allergy to gadolinium-DTPA,\r<br>· Subject has a history of alcohol or drug abuse,\r<br>· Subject has previously participated in this study,\r<br>· Subject has moderate to severe renal impairment,\r<br>· Subject is pregnant or lactating,\r<br>· Subject has any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol, or to complete the study.<br>", "condition": "Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. <br>MedDRA version: 14.1\nLevel: PT\nClassification code 10028245\nTerm: Multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]", "intervention": "<br>Trade Name: Rebif<br><br><br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Interferon-beta 1a<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 44-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Subcutaneous use<br><br>", "primary_outcome": "Main Objective: Primary objective: to investigate whether RNF treatment initiated after the first clinical event versus delayed treatment results in the prolongation of time to CDMS conversion up to Month 36 since randomisation in study 27025.;Secondary Objective: · To investigate whether RNF treatment initiated after the first clinical event versus delayed treatment results in the prolongation of time to CDMS conversion up to Month 60 since randomisation in study 27025.<br>· To investigate whether RNF treatment initiated after the first clinical event versus delayed treatment delays disability (including development of secondary progressive MS) and reduces disease activity (including the annual relapse rate) in the long term (up to Month 36 and up to Month 60 since randomisation in study 27025).<br>· To assess the long-term safety profile of RNF (up to Month 36 and up to Month 60 since randomisation in study 27025).;Primary end point(s): The primary endpoint is the time to conversion to CDMS, defined by either a second attack or a sustained increase (=1.5 points) in the EDSS score (as defined in study 27025), from randomisation in study 27025 up to Month 36.;Timepoint(s) of evaluation of this end point: Up to 36 months.", "secondary_outcome": "Secondary end point(s): Secondary endpoints up to Month 36 from randomisation in study 27025:\r<br>.Time to confirmed EDSS progression (=1.0 point, confirmed during a visit performed 6\r<br>months later) from randomisation in study 27025 up to Month 36.\r<br>.MRI endpoints including, but not limited to:\r<br>.Mean number of combined unique active MRI lesions per subject per scan.\r<br>.Mean number of new T2 lesions per subject per scan.\r<br>.Mean number of new T1 lesions per subject per scan.\r<br>.T2 lesion load.\r<br>.T1 lesion load.\r<br>.Mean number of new Gd-enhancing lesions per subject per scan.\r<br>.Brain volume.\r<br>.Other secondary endpoints including:\r<br>.Percentage of subjects with conversion to McDonald MS.\r<br>.Cognition by means of PASAT.\r<br>.Proportion of relapse-free subjects.\r<br>.EDSS changes from baseline over time.\r<br>.Changes from baseline in MSFC (composite score, timed-25-footwalk, 9-hole-pegtest\r<br>and 3’’PASAT) over time.\r<br>Secondary endpoints up to Month 60 from randomisation in study 27025:\r<br>Time to conversion to CDMS from randomisation in study 27025 up to Month 60.\r<br>.Time to confirmed EDSS progression from randomisation in study 27025 up to Month\r<br>60.\r<br>.All other secondary endpoints described above for up to Month 36 (MRI endpoints and\r<br>other).\r<br>Safety endpoints evaluated up to Month 36 and up to Month 60 from randomisation in\r<br>study 27025 include:\r<br>.Incidence, severity and relationship to the trial drug of AEs,\r<br>.SAEs,\r<br>.AEs leading to permanent treatment discontinuation,\r<br>.Clinically significant changes in laboratory tests (according to laboratory reference\r<br>ranges),\r<br>.Use of concomitant medications,\r<br>.Development of BAbs and NAbs to IFN-beta-1a, and\r<br>.Vital signs.;Timepoint(s) of evaluation of this end point: Up to 36 months or up to 60 months", "secondary_id": "28981;NCT00813709", "source_support": "Merck Serono S.A. - Geneva", "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": 3605, "title": "Sunphenon in Progressive Forms of Multiple Sclerosis", "summary": null, "published_date": "2008-11-28T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.985420Z", "link": "https://clinicaltrials.gov/show/NCT00799890", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00799890" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "11234701", "last_refreshed_on": "2021-08-10", "scientific_title": "Monocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis", "primary_sponsor": "Friedemann Paul", "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": "All", "date_enrollement": "2009-05-27", "target_size": "61", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).", "phase": "Phase 2/Phase 3", "countries": "Germany", "contact_firstname": "", "contact_lastname": "Friedemann Paul, Dr.", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Charite University (NeuroCure Clinical Research Center)", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Primary or secondary chronic progressive multiple sclerosis (ms)\r<br>\r<br> - EDSS 3-8\r<br>\r<br> - Age 18-65\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Relapsing-remitting ms\r<br>\r<br> - Immunodulatoric or immunosuppressive therapy\r<br>\r<br> - pretreatment with Mitoxantron, Natalizumab, Rituximab, Azathioprin <2 month before\r<br> screening\r<br>\r<br> - pretreatment with Glairameracetat or beta-Interferons <4 weeks before screening\r<br>\r<br> - signs of hepatic dysfunction\r<br>\r<br> - active ulcus ventriculi or duodeni\r<br>\r<br> - neoplasias if not cured >1 year before screening\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: Sunphenon EGCG;Drug: Placebo", "primary_outcome": "brain atrophy", "secondary_outcome": "new T2 lesions;reduction of the NAA/Cr-ratio in MR-spectroscopy;progression of disability such as cognitive disorders;number of AEs", "secondary_id": "SUPREMES-01", "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": 3604, "title": "An Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis who have completed Treatment in the study 205MS201 (SELECT)", "summary": null, "published_date": "2008-11-28T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.963520Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005559-46", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-005559-46-CZ" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "3465010", "last_refreshed_on": "2013-08-26", "scientific_title": "A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) - SELECTION", "primary_sponsor": "Biogen Idec Ltd.", "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": "2009-01-23", "target_size": "600", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: no\nCross over: no\nOther: yes\nOther trial design description: Multicenter\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no\nNumber of treatment arms in the trial: 3", "phase": null, "countries": "Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India", "contact_firstname": "Clinical Trial Information Desk", "contact_lastname": null, "contact_address": "Innovation House; 70 Norden Road", "contact_email": "[email protected]", "contact_tel": null, "contact_affiliation": "Biogen Idec", "inclusion_criteria": "Inclusion criteria: <br>Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of\r<br>randomization:\r<br>1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected\r<br>health information (PHI) in accordance with national and local subject\r<br>privacy regulations.\r<br>2. Must be a subject from Study 205MS201 for at least 52 weeks and must have been compliant with the 205MS201 protocol in the opinion of the Investigator.\r<br>3. Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.\r<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 600<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 0<br>", "exclusion_criteria": "Exclusion criteria: <br>Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of\r<br>randomization:\r<br>1. Subjects with any significant change in their medical status from Study 205MS201 that would preclude administration of DAC HYP\r<br>including laboratory results or a current clinically-significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS201. The Investigator must rereview\r<br>the subject's medical fitness for participation and must consider any diseases that would preclude treatment with DAC HYP.\r<br>2. Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo.\r<br>3. Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant IFN-beta.\r<br>4. Current enrollment in any investigational drug study other than 205MS201.\r<br>5. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or\r<br>social) that is likely to affect the subject's ability to comply with the protocol.\r<br>6. Other unspecified reasons that, in the opinion of the Investigator or the Biogen Idec Medical Director, make the subject unsuitable for enrollment.<br>", "condition": "Relapsing-remitting Multiple Sclerosis <br>MedDRA version: 14.0\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]", "intervention": "<br>Product Name: DACLIZUMAB HYP<br>Product Code: BIIB019<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Daclizumab with Greek suufix<br>Current Sponsor code: BIIB019<br>Other descriptive name: Daclizumab HYP (DAC HYP)<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Subcutaneous use<br><br>Product Name: DACLIZUMAB HYP<br>Product Code: BIIB019<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Daclizumab with Greek suufix<br>Current Sponsor code: BIIB019<br>Other descriptive name: Daclizumab HYP (DAC HYP)<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br><br>", "primary_outcome": "Main Objective: To assess the safety and immunogenicity of extended treatment with<br>DAC HYP. This evaluation will include the following major components:<br>• An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who have completed 52 weeks of active therapy with DAC HYP in Study 205MS201.<br>• An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.<br>• An assessment of safety and immunogenicity during re-initiation of therapy with DAC HYP after a 6-month washout period.<br>• An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during<br>study 205MS201<br>Note: The 6-month washout period is defined by the 24-week period between the last scheduled administration of DAC HYP at the Week 48 visit in 205MS201 and the re-initiation of DAC HYP at the Week 20 visit in 205MS202.;Secondary Objective: Secondary objective of this study is:<br>• to assess the durability of the effect of DAC HYP on MS disease activity as measured by brain magnetic resonance imaging (MRI) scans<br>and clinical MS relapses.;Primary end point(s): The primary end points of the study are safety as defined by the incidence of adverse events, change in laboratory evaluations, vital signs, physical examinations and immunogenicity as defined by the development of antibodies to DAC HYP.;Timepoint(s) of evaluation of this end point: Adverse events- as events occur<br>Lab evaluations and vital signs- at baseline and then monthly<br>Physical examinations- at baseline, and then at wk 8, 20, 32, 44, 52, 60, 72 and at early termination visit if applicable<br>Immunogenicity- at baseline, and then at wk 4, 8, 12, 16, 20, 32, 40, 52, 72 and at early termination visit if applicable", "secondary_outcome": "Secondary end point(s): The secondary endpoint is to assess the durability of the effect of DAC HYP on MS disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.\r<br>;Timepoint(s) of evaluation of this end point: MRI-at baseline and then at wk 20, 52 and at early termination visit if applicable\r<br>Clinical relapse- as events occur", "secondary_id": "205MS202", "source_support": "Biogen Idec Ltd", "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": 3603, "title": "A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis", "summary": null, "published_date": "2008-12-12T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.942756Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005304-93", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-005304-93-GB" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "2469555", "last_refreshed_on": "2012-03-19", "scientific_title": "A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis", "primary_sponsor": "North Bristol Trust", "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": "2009-02-13", "target_size": null, "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: yes\nDouble blind: no\nParallel group: no\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no", "phase": null, "countries": "United Kingdom", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>Age 18-65 with established MS<br>Acute flare-up requiring treatment with a corticosteroid<br>Able to attend for study investigations and assessments<br>Willing and able to provide informed consent<br><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>Previous diagnosis of osteoporosis<br>Bone active therapy within previous 12 months (excluding calcium and low dose vitamin D), previous treatment with bisphosphonate at any time.<br>Associated disorder which may influence bone metabolism<br>Moderate to severe renal impairment (creatinine>150)<br>Cardiac failure<br>Possibility of pregnancy<br>Breast feeding<br><br>", "condition": "Bone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease. <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10048393\nTerm: Multiple sclerosis relapse\n <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10065687\nTerm: Bone loss", "intervention": "<br>Trade Name: Aclasta 5mg solution for infusion<br>Product Name: Aclasta<br>Product Code: ZOL446H<br>Pharmaceutical Form: Solution for infusion<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br>", "primary_outcome": "Main Objective: Patients with MS who are experiencing an exacerbation of their disease symptoms are traditionally treated with either a 3 day course of intravenous high dose corticosteroids (methylprednisolone) or sometimes a 5 day course of oral corticosteroids (methylprednisolone).The principal objective is to discover whether giving a single intravenous infusion of a bisphosphonate, zoledronate, immediately prior to the corticosteroid therapy will prevent the bone thinning effect of the steroid and the associated increase in fracture risk.<br>;Secondary Objective: The secondary objective is to discover whether those patients given zoledronate had a prolonged period of protection for their bones, therefore reducing their risk of fracture.;Primary end point(s): The hypothesis is that a single zoledronate infusion prior to a course of corticosteroid will prevent the rapid increase in bone resorption which normally occurs in response to high dose steroid therapy. The primary outcome will be a significant difference in serum CTX according to treatment group at day 7 the study.", "secondary_outcome": null, "secondary_id": "ZOL40/02", "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": 3602, "title": "An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study", "summary": null, "published_date": "2008-12-12T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.921298Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005021-11", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-005021-11-BE" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "2633340", "last_refreshed_on": "2012-06-12", "scientific_title": "An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study", "primary_sponsor": "Merck Serono SA - Geneva, An affiliate of Merck KGaA, Darmstadt, Germany", "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": "2009-10-14", "target_size": "68", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: no\nRandomised: \nOpen: \nSingle blind: \nDouble blind: \nParallel group: \nCross over: \nOther: \nIf controlled, specify comparator, Other Medicinial Product: \nPlacebo: \nOther:", "phase": null, "countries": "Czech Republic;Belgium;France;Sweden", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>Inclusion Criteria for Participation in Study 28851:<br>- Participation in study 28063.<br>- Completion of Week 36 visit of the core study 28063<br>- Willingness and ability to comply with study procedures for the duration of the study.<br>- Voluntary provision of written informed consent (including, for the USA, subject<br>authorization under the Health Insurance Portability and Accountability Act (HIPAA)),<br>given before any study-related procedure that is not part of normal medical care and<br>with the understanding that the subject may withdraw consent at any time without<br>prejudice to his or her future medical care.<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) yes<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>Exclusion Criteria for Participation in Study 28851:<br>- Premature discontinuation of core study 28063.<br>", "condition": "Relapsing multiple sclerosis <br>MedDRA version: 9.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis", "intervention": "<br>Product Name: atacicept<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: atacicept<br>Other descriptive name: TACI-Fc5<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 25-<br><br>Product Name: atacicept<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: atacicept<br>Other descriptive name: TACI-Fc5<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 75-<br><br>Product Name: atacicept<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: atacicept<br>Other descriptive name: TACI-Fc5<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 150-<br><br>", "primary_outcome": "Main Objective: The main objective of the study is to monitor the long-term safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS).;Secondary Objective: - To describe the long-term course of measures of MS disease activity and progression, such as relapse activity and EDSS, under atacicept treatment in subjects with RMS.<br>- To describe the long-term effects of atacicept treatment on inflammation and CNS tissue integrity as measured by magnetic resonance imaging (MRI). <br>- To study atacicept’s long-term biological activity by the assessment of pharmacodynamic (PD) and pharmacogenomic markers.<br>- To explore atacicept’s immunogenicity, in particular the potential late development and persistence of neutralizing antibodies.<br>;Primary end point(s): Parameters related to the main study objective:<br>- Nature and severity of adverse events (AEs) and serious AEs (SAEs), in particular infections and malignancies.<br>- Hematology and blood chemistry laboratory parameters.<br>- Injection site reactions.<br>- Vital signs, ECGs.<br>- IgG levels, in particular IgG level <3 g/L at any time during the study.<br>- Immunogenicity: development of NAb to atacicept, persistence of NAb in subjects who become NAb-positive either in the core study or in the extension study (if this occurs).<br><br>", "secondary_outcome": null, "secondary_id": "28851", "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": 3601, "title": "Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis", "summary": null, "published_date": "2008-12-16T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.900757Z", "link": "http://clinicaltrials.gov/show/NCT00819195", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00819195" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "4652138", "last_refreshed_on": "2015-02-19", "scientific_title": "Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis", "primary_sponsor": "University of California, San Francisco", "retrospective_flag": "No", "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": "2008-12-27", "target_size": "17", "study_type": "Observational", "study_design": "Observational Model: Cohort, Time Perspective: Prospective", "phase": "N/A", "countries": "United States", "contact_firstname": "", "contact_lastname": "Scott S. Zamvil, M.D. Ph.D.", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "UCSF Department of Neurology", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Relapsing-remitting (RR) MS patients (McDonald criteria)\r<br>\r<br> - Ages 18-55\r<br>\r<br> - Males and females\r<br>\r<br> - EDSS score =5\r<br>\r<br> - No prior treatment with Copaxone\r<br>\r<br> - Prior treatment with corticosteroids or interferon-beta (-1a or -1b) is acceptable,\r<br> provided there is a washout period of at least one month\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Treatment with Tysabri, Novantrone or cyclophosphamide\r<br>\r<br> - Treatment with other immunomodulatory therapies (e.g. imuran, mycophenolate or\r<br> methotrexate)\r<br>\r<br> - Primary-progressive (PP) and secondary-progressive (SP) multiple sclerosis\r<br>\r<br> - Pregnancy\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: Glatiramer acetate", "primary_outcome": "Production of inflammatory cytokines by monocytes and naive T cells.", "secondary_outcome": null, "secondary_id": "10-03877", "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": 3600, "title": "", "summary": null, "published_date": "2006-05-12T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.879806Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003696-12", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2006-003696-12-BE" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "2811189", "last_refreshed_on": "2012-10-09", "scientific_title": "A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A", "primary_sponsor": "Biogen Idec Ltd.", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Not Recruiting", "other_records": "Yes", "inclusion_agemin": "", "inclusion_agemax": "", "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2007-02-03", "target_size": "1011", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\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": "Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden", "contact_firstname": "", "contact_lastname": "", "contact_address": "", "contact_email": "", "contact_tel": "", "contact_affiliation": "", "inclusion_criteria": "Inclusion criteria: <br>1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).<br>2. Aged 18 to 55 years old, inclusive, at the time of informed consent.<br>3. Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4<br>(Polman et al, 2005).<br>4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.<br>5. Must have experienced at least 1 relapse within the 12 months prior to randomization,with a prior brain MRI demonstrating lesion(s) consistent with MS or show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.<br>6. Male subjects and female subjects of child-bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.<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>Medical History<br>1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.<br>2. Unable to perform the Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) with both upper extremities, and PASAT 3.<br>3. Unable to perform visual function tests.<br>4. History of malignancy, unless an exception is granted by the Biogen Idec Medical Director. (Subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).<br>5. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.<br>6. History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that would preclude participation in a clinical trial.<br>7. History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS) and/or other major disease that would preclude participation in a clinical trial.<br>8. History of human immunodeficiency virus (HIV).<br>9. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.<br>10. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.<br>11. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.<br>12. Any of the following abnormal blood tests at screening:<br>• alanine transaminase/serum glutamate-pyruvate transaminase (ALT/SGPT), or<br>aspartate transaminase/serum glutamic-oxaloacetic transaminase (AST/SGOT), or<br>gamma-glutamyl-transferase (GGT) =2 times the upper limit of normal (ULN)<br>• leukocytes <3500/mm3<br>• eosinophils >0.7 × 10³/µL or >0.7 GI/L.<br>13. Any of the following abnormal urine tests at screening confirmed by the second urinalysis 2 weeks later:<br>• proteinuria (1+ or greater)<br>• hematuria, without known etiology (e.g. urinary tract infection, menses)<br>• glycosuria, without known etiology (e.g. recent steroid use, elevated serum glucose)<br><br>Treatment History<br>14. Any previous treatment with FUMADERM® or BG00012 (FAG-201).<br>15. Prior treatment with any of the following:<br>• total lymphoid irradiation<br>• cladribine<br>• T-cell or T-cell receptor vaccination<br>• any therapeutic monoclonal antibody, with the exception of TYSABRI®<br>(natalizumab) (see exclusion #17)<br>16. Prior treatment with any of the following within 1 year prior to randomization:<br>• mitoxantrone<br>• cyclophosphamide<br>17. Prior treatment with any of the following medications or procedures within the 6 months<br>prior to randomization:<br>• cyclosporine<br>• azathioprine<br>• methotrexate<br>• natalizumab (TYSABRI®)<br>• mycophenolate mofetil<br>• intravenous immunoglobulin<br>• plasmapheresis or cytapheresis.<br>18. Prior treatment with any of the following within the 3 months prior to randomization:<br>• subcutaneous or oral glatiramer acetate<br>• interferon-alpha<br>• interferon-beta.<br>19. Treatment with any of the following medications within the 50 days prior to<br>randomization:<br>• steroids (intravenous [IV] or oral corticosteroid treatment, including agents that may act through t", "condition": "Relapsing-Remitting Multiple Sclerosis <br>MedDRA version: 8.1\nLevel: LLT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis", "intervention": "<br>Product Name: BG00012<br>Pharmaceutical Form: Capsule, hard<br>CAS Number: 624497<br>Other descriptive name: DIMETHYL FUMARATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 120-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: The primary objective of this study is to determine whether BG00012, when compared with placebo, is effective in reducing the proportion of relapsing subjects at 2 years.<br>;Secondary Objective: To determine whether BG00012, when compared with placebo, is effective in:<br><br>- reducing the total number of new or newly enlarging T2 hyperintense lesions on brain MRI scans in a subset of subjects at 2 years;<br><br>- reducing the total number of Gd-enhancing lesions on 3 brain MRI scans taken at 2 years in a subset of subjects;<br><br>- reducing the rate of clinical relapses at 2 years;<br><br>- slowing the progression of disability at 2 years as measured by at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) from the baseline EDSS is greater than or equal to 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks.;Primary end point(s): Proportion of subjects relapsed at 2 years", "secondary_outcome": null, "secondary_id": "109MS301;N/A", "source_support": "", "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 } ] }