Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=77
{ "count": 4827, "next": "http://api.gregory-ms.com/trials/?format=api&page=78", "previous": "http://api.gregory-ms.com/trials/?format=api&page=76", "results": [ { "trial_id": 3584, "title": "Recombinant IFN alpha-2b for relapsing –remitting multiple sclerosis.", "summary": null, "published_date": "2009-11-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.503800Z", "link": "https://rpcec.sld.cu/en/trials/RPCEC00000073-En", "source": "WHO XML import", "relevant": null, "identifiers": { "rpcec": "RPCEC00000073" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13834725", "last_refreshed_on": "2024-04-01", "scientific_title": "Recombinant IFN alpha-2b for relapsing –remitting multiple sclerosis. Phase III, randomized, double blind, placebo-controlled clinical trial.", "primary_sponsor": "Center for Genetic Engineering and Biotechnology, La Habana.", "retrospective_flag": "No", "date_registration": null, "source_register": "RPCEC", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "18 years", "inclusion_agemax": "50 years", "inclusion_gender": "Male/Female", "date_enrollement": "1995-05-13", "target_size": "159", "study_type": "Interventional", "study_design": "Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment", "phase": "2-3", "countries": "Cuba", "contact_firstname": "Giselle", "contact_lastname": "Rol", "contact_address": "31st Ave. between 158 and 190, Cubanacan, Playa.", "contact_email": "[email protected]", "contact_tel": null, "contact_affiliation": "Center for Genetic Engineering and Biothecnology (CIGB), in Havana.", "inclusion_criteria": "Inclusion criteria: 1.Diagnosis of relapsing remitting multiple sclerosis defined according to Poser criteria. 2.Clinically stable patients for at least 30 days without having received any treatment with steroids during this time. 3.Duration of the disease of two years having 2 relapses at least. 4.Score of 6.5 or less in the Kurtzke EDSS scale. 5.18 to 50 years of age. 6.Patient willingness through informed consent signature.", "exclusion_criteria": "Exclusion criteria: 1.Being in the acute phase of the disease. 2.Progressive clinical form. 3.Presence of any disease explaining the clinical symptoms or unfavorable outcome having a defined therapeutic behavior. 4.Pregnancy or puerpery. 5.Women in fertile age during contraceptive hormonal therapy. 6.Having received treatment with aziathroprina or Cyclofosfamide during the last year. 7.Uncontrolled chronic disease (heart, liver or kidney failure). 8.IFN hypersensitivity background.", "condition": "Relapsing-remitting multiple sclerosis, clinically defined according to Poser criteria (Ann Neurol 1983; 13: 227-231).", "intervention": "Group I: Recombinant IFN alpha-2b, 10 x 106 UI by intramuscular route, twice a week separated by 3 days at least for two years. Group II: Recombinant IFN alpha-2b, 3 x 106 UI by intramuscular route, twice a week separated by 3 days at least for two years. Group III: Placebo by intramuscular route, twice a week separated by 3 days at least for two years.", "primary_outcome": "The mean number of relapses per patient in each group during the two years of treatment.", "secondary_outcome": "1.Proportion of patients without relapses during the two years of treatment. 2.Variation in the Scripps-NRS scale at the beginning, annually and during relapses. 3.Variations in the degree of disability according to the Kurtzke EDSS at the beginning and annually. 4.Magnetic Resonance Imaging at the beginning and annually in a group of cases. 5.Evaluation of the cognitive function in a group of patients. 6.Treatment safety (occurrence of adverse events).", "secondary_id": "IG/IAI/EM/9501.", "source_support": "Heber Biotec S.A. and Cuban Ministry of Public Health.", "ethics_review_status": null, "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": 3583, "title": "The Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Multiple Sclerosis Patients", "summary": null, "published_date": "2009-12-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.485911Z", "link": "http://clinicaltrials.gov/show/NCT00843128", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00843128" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4653957", "last_refreshed_on": "2015-02-19", "scientific_title": "Phase II Study of the Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Acute Stroke Patients: A Randomized Controlled Trial.", "primary_sponsor": "Hadassah Medical Organization", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "Both", "date_enrollement": "2009-03-19", "target_size": "40", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment", "phase": "Phase 2", "countries": "Israel", "contact_firstname": "", "contact_lastname": "Zeev Meiner, M.D.", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Hadassah Medical Organization", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. chronic or secondary progressive MS patients with EDSS between 5.5-7,\r<br>\r<br> 2. stable treatment 3 months before study entry.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Other generalized diseases.\r<br>\r<br> 2. Pregnancy.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Device: robot-assisted gait training (RAGT);Device: conventional walking training (CWT)", "primary_outcome": "Functional Ambulatory Capacity (FAC) scale and the 6-minutes walking distance", "secondary_outcome": "Time up & Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS score, FIM score and SF36 questioner for quality of life.", "secondary_id": "0558-08-HMO-CTIL", "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": 3582, "title": "A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis", "summary": null, "published_date": "2009-02-16T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.463697Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008719-25", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-008719-25-DE" }, "categories": [ { "category_id": 13, "category_description": "Siponimod (also known as BAF312 or Mayzent) is a tablet being developed for secondary progressive MS by Novartis Pharmaceuticals. It was licensed by the European Medicines Agency (EMA) on Monday 20 January 2020.\n\nhttps://www.mssociety.org.uk/research/explore-our-research/emerging-research-and-treatments/explore-treatments-in-trials/siponimod", "category_name": "Siponimod", "category_slug": "siponimod", "category_terms": [ "siponimod", "BAF312", "Mayzent" ], "article_count": 46 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "2579327", "last_refreshed_on": "2012-05-01", "scientific_title": "A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis", "primary_sponsor": "Novartis Pharma Services 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": null, "target_size": "275", "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: yes\nOther trial design description: adaptive dose-ranging\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no", "phase": null, "countries": "Hungary;Finland;Germany;Spain;Italy", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>1. Patients must give written informed consent before any assessment is performed<br>2. 18 through 55 years of age inclusive<br>3. Male or female<br>4. Females of childbearing potential:<br>• must have a negative pregnancy test at Baseline prior to entry into the double-blind treatment phase<br>• must simultaneously use two forms of effective contraception (either partner) during the treatment and for one<br>months or one menstrual cycle, whichever is longer after discontinuation of the study drug<br>• if either post-menopausal for 12 months prior to randomization or surgically sterile (through hysterectomy<br>or bilateral oophorectomy, if documented), are not required to use birth control (refer to Section 8.3 for more<br>details)<br>5. Diagnosis of MS as defined by revised McDonald criteria (see Appendix 4)<br>6. A relapsing-remitting course of disease with<br>• at least 1 documented relapse during the previous year, or<br>• 2 documented relapses during the previous 2 years, or<br>• a positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a<br>second scan may be obtained 1 month later)<br>7. An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization<br>8. Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to<br>randomization<br>9. Patients who decline initiation or continuation of treatment with available disease modifying drugs for MS, for<br>whatever reason, after having been informed about their respective benefits and possible adverse events by the<br>investigator.<br>10. Is willing to refrain from submersion in water while wearing the MCT adherent device during dose titration<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. Another type of MS than RRMS<br>2. History of chronic disease of the immune system other than MS, or a known immunodeficiency syndrome<br>3. Malignancy (except for successfully-treated basal or squamous cell carcinoma of skin)<br>4. Known, or ‘new’ diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes a patient should be further evaluated)<br>5. Macular edema during pre-randomization<br>6. Active systemic bacterial, viral or fungal infections, or AIDS, hepatitis B, hepatitis C infection defined as a positive HIV AB, hepatitis B surface AG or hepatitis C AB tests<br>7. Negative for varicella-zoster virus IgG AB at screening<br>8. Live or live attenuated vaccination within 2 m<br>9. Total lymphoid irradiation or bone marrow transplantation<br>10. Have been treated with:<br>• ACTH or oral or injected corticosteroids within 1 m<br>• IFN-ß or glatiramer acetate within 3 m<br>• immunosuppressive medications such as azathioprine or methotrexate within<br>6 m<br>• immunoglobulins and/or monoclonal ABs (including natalizumab) within 6 m (this rule does not apply for alemtuzumab, rituximab)<br>• alemtuzumab, rituximab, cladribine, cyclophosphamide, mitoxantrone, or other immunosuppressive treatments with effects potentially lasting over 6 m, at any time<br>11. Any medically unstable condition, as assessed by the primary treating physician<br>12. Any of the following CV conditions<br>• history or presence of stable or unstable IHD, MI, myocarditis or cardiomyopathy<br>• history of Raynaud’s disease<br>• cardiac failure (NYHA class II - IV) at screening and/or at baseline, or any severe cardiac disease as determined by the investigator<br>• history of cardiac arrest<br>• history of symptomatic bradycardia<br>• resting pulse rate < 55 bpm<br>• history or presence of a clinically relevant impairment of cardiac conduction including sick sinus syndrome, sino-atrial block<br>• clinically significant AVB, bundle branch block or an increased QTc interval > 440 msec on screening ECG<br>• history or presence of symptomatic arrhythmia or arrhythmia requiring treatment or being otherwise of clinical significance<br>• arterial hypertension, uncontrolled by medication<br>• treatment with medication that impairs cardiac conduction<br>• history of syncopes of suspected cardiac origin<br>• history of catheter ablation<br>13. Any of the following pulmonary conditions:<br>• severe respiratory disease or pulmonary fibrosis<br>• tuberculosis, except for history of successfully treated TB or history of prophylactic treatment after positive PPD skin reaction<br>• abnormal chest High Resolution Computer Tomography (HRCT), chest X-Ray or chest MRI suggestive of active pulmonary disease<br>• abnormal Pulmonary Function Tests: forced expiratory volume in 1 second (FEV1) or forced vital capacity<br>(FVC) values lower than 70% of predicted value<br>• patients receiving chronic (daily) therapies for asthma<br>14. Any of the following hepatic conditions:<br>• chronic liver or biliary disease<br>• total bilirubin >ULN unless in context of Gilbert’s syndrome<br>• conjugated bilirubin >ULN<br>• alkaline phosphatase (AP) >1.5 x ULN<br>• AST or SGOT, ALT or SGPT >2 x ULN<br>• GGT >3 x ULN<br>15. Any of the following abnormal laboratory values:<br>• potassium >ULN<br>• serum creatinine > 1.7 mg/dL (150 µmol/L)<br>• white blood cell count < 3,500/mm3 (< 3.5 x 109/L)<br>• lymphocyte count < 800/mm3 (< 0.8 x 109/L)<br>16. Any of the following neurological/psychiatric disorders:<br>• history or presence of substance abuse (any illicit or prescription drugs or alcohol)<br>• progressive neurological disorde", "condition": "Relapsing-remitting multiple sclerosis <br>MedDRA version: 9.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis", "intervention": "<br>Product Code: BAF312<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: BAF312<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.25-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>Product Code: BAF312<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: BAF312<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>Product Code: BAF312<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: BAF312<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 4-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>Product Code: BAF312<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: BAF312<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>Product Name: BAF312<br>Product Code: BAF312<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: BAF312<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.1-<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 of this study is to evaluate the dose response relationship among five doses of BAF312 and placebo during 3 months of treatment in patients with RRMS, as measured by the number of combined unique active [MRI] lesions (CUAL). ;Secondary Objective: • To evaluate the safety and tolerability (including blood pressure effects) of BAF312 during 6 months and 3 months of treatment in MS patients<br>• To evaluate the dose response relationship of BAF312 and placebo during 6 months of treatment in patients with RRMS, as measured by CUAL<br>• To explore the effect of BAF312 on the number of relapses and thereof derived measures (e.g. annualized relapse rate (ARR), proportion of relapse-free patients)<br>• To explore the correlation of the course of the lymphocyte count with paraclinical (MRI activity) and clinical course<br>;Primary end point(s): Monthly number of combined unique active MRI lesions (CUAL) during 3 months of treatment. Combined unique active lesions are defined as new gadolinium [Gd]-enhancing lesions on T1-weighted MRI scans or new or enlarging lesions on T2-weighted MRI scans, without double-counting of lesions.<br>", "secondary_outcome": null, "secondary_id": "CBAF312A2201", "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": 3581, "title": "Atacicept in Multiple Sclerosis Extension Study, Phase II", "summary": null, "published_date": "2009-02-26T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.439202Z", "link": "https://clinicaltrials.gov/show/NCT00853762", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00853762" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6613347", "last_refreshed_on": "2017-12-16", "scientific_title": "An Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)", "primary_sponsor": "EMD Serono", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "60 Years", "inclusion_gender": "All", "date_enrollement": "2009-03-19", "target_size": "74", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).", "phase": "Phase 2", "countries": "United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;United States;United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;United States;United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;United States;United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;United States;United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;United States", "contact_firstname": "; ; ; ;", "contact_lastname": "Daniel Mikol, MD, PhD;Daniel Mikol, MD, PhD;Daniel Mikol, MD, PhD;Daniel Mikol, MD, PhD;Daniel Mikol, MD, PhD", "contact_address": null, "contact_email": ";;;;", "contact_tel": ";;;;", "contact_affiliation": "EMD Serono;EMD Serono;EMD Serono;EMD Serono;EMD Serono", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Participation in study 28063.\r<br>\r<br> - Completion of Week 36 visit of the core study 28063.\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - Voluntary provision of written informed consent (including, for the USA, subject\r<br> authorization under the Health Insurance Portability and Accountability Act (HIPAA)),\r<br> given before any study-related procedure that is not part of normal medical care and\r<br> with the understanding that the subject may withdraw consent at any time without\r<br> prejudice to his or her future medical care.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Premature discontinuation of core study 28063.\r<br>\r<br> - Subjects who meet criteria listed below will receive IMP in study 28851:\r<br>\r<br> - Subjects who are eligible for participation in extension study 28851 but do not\r<br> meet these criteria will not be treated with IMP but will undergo scheduled\r<br> visits, irrespective of their treatment.\r<br>\r<br> - All subjects must satisfy the following criteria before Extension Study Day 1 (D1-EXT;\r<br> defined as the first day of dosing in the extension study) to be eligible for\r<br> treatment with IMP:\r<br>\r<br> - Eligibility for participation in extension study 28851.\r<br>\r<br> - For women of childbearing potential, a negative urine pregnancy test at\r<br> eligibility assessment.\r<br>\r<br> - Female subjects of childbearing potential must be willing to avoid pregnancy by\r<br> using an adequate method of contraception for four (4) weeks before the first\r<br> dose administered within the extension study, during the study and for twelve\r<br> (12) weeks after the last dose of trial medication. Adequate contraception is\r<br> defined as two barrier methods, or one barrier method with spermicide, or an\r<br> intrauterine device, or use of a combined oral female hormonal contraceptive (or\r<br> the definitions requested by health authorities and locally amended in the core\r<br> study 28063). For the purposes of this trial, women of childbearing potential are\r<br> defined as: \"All female subjects after puberty unless they are post-menopausal\r<br> for at least two years or are surgically sterile\" (For Germany Only: Female\r<br> subjects of childbearing potential must be willing to avoid pregnancy by using\r<br> highly effective methods of contraception for approximately four (4) weeks prior\r<br> to D1-EXT, during and for twelve (12) weeks after the last dose of trial\r<br> medication. This requirement does not apply to surgically sterile subjects or to\r<br> subjects who are postmenopausal for at least 2 years. Highly effective\r<br> contraception is defined as any method or combination of methods which result in\r<br> a low failure rate (i.e. less than (<) 1% per year) when used consistently and\r<br> correctly, such as implants, injectables, combined oral contraceptives, sexual\r<br> abstinence, vasectomized partner, 2 barrier methods, or 1 barrier method with\r<br> spermicide)\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - To be eligible for treatment with investigational medicinal product (IMP) in study\r<br> 28851, the subjects must not meet any of the following criteria:\r<br>\r<br> - Non-eligibility for participation in extension study 28851 (premature discontinuation\r<br> of core study 28063).\r<br>\r<br> - Major protocol violation or non-compliance in the core study.\r<br>\r<br> - Use of prohibited immunomodulatory / immunosuppressive therapies\r<br>\r<br> - Serum immunoglobulin G (IgG) level <3 gram per liter (g/L) if the subject received\r<br> atacicept in the core study, or serum IgG level <6 g/L if the subject received placebo\r<br> in the core study (to protect the blinding of the core study, the IgG level will be\r<br> communicated to the treating physician only if it is too low for extension study\r<br> participation and only after all Week 36 assessments performed within the core study\r<br> have been completed).\r<br>\r<br> - Any condition, including laboratory findings that, in the opinion of the Investigator,\r<br> constitutes a risk or a contraindication for participation in the extension study, or\r<br> that could interfere with the study objectives, conduct or evaluation.\r<br>\r<br> - Known active clinically significant acute or chronic infection, or any major episode\r<br> of infection requiring hospitalization or treatment with parenteral anti-infectives.\r<br>\r<br> - Investigator judgement that treatment of the subject with atacicept in the extension\r<br> study is not appropriate.\r<br>\r<br> - Aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or alkaline\r<br> phosphatase (AP) level greater than (>)2.5 x upper limit of normal (ULN), or total\r<br> bilirubin >1.5 x ULN at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality in any hematological test (e.g. hemoglobin <100 g/L\r<br> (6.21 millimoles per liter [mmol/L]), white blood cells <3 x 10^9 per liter (/L),\r<br> platelets <100 x 10^9/L) at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality on electrocardiogram (ECG) performed at eligibility\r<br> assessment.\r<br>\r<br> - Presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive\r<br> heart failure at Week 36 of the core study.\r<br>\r<br> - Moderate to severe renal impairment (creatinine clearance <50 milliliter per minute\r<br> (mL/min) according to Cockcroft-Gault equation).\r<br>\r<br> - Allergy or hypersensitivity to gadolinium (Gd).\r<br>\r<br> - Allergy or hypersensitivity to atacicept or to any of the components of the formulated\r<br> atacicept.\r<br>\r<br> - Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Participation in study 28063.\r<br>\r<br> - Completion of Week 36 visit of the core study 28063.\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - Voluntary provision of written informed consent (including, for the USA, subject\r<br> authorization under the Health Insurance Portability and Accountability Act (HIPAA)),\r<br> given before any study-related procedure that is not part of normal medical care and\r<br> with the understanding that the subject may withdraw consent at any time without\r<br> prejudice to his or her future medical care.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Premature discontinuation of core study 28063.\r<br>\r<br> - Subjects who meet criteria listed below will receive IMP in study 28851:\r<br>\r<br> - Subjects who are eligible for participation in extension study 28851 but do not\r<br> meet these criteria will not be treated with IMP but will undergo scheduled\r<br> visits, irrespective of their treatment.\r<br>\r<br> - All subjects must satisfy the following criteria before Extension Study Day 1 (D1-EXT;\r<br> defined as the first day of dosing in the extension study) to be eligible for\r<br> treatment with IMP:\r<br>\r<br> - Eligibility for participation in extension study 28851.\r<br>\r<br> - For women of childbearing potential, a negative urine pregnancy test at\r<br> eligibility assessment.\r<br>\r<br> - Female subjects of childbearing potential must be willing to avoid pregnancy by\r<br> using an adequate method of contraception for four (4) weeks before the first\r<br> dose administered within the extension study, during the study and for twelve\r<br> (12) weeks after the last dose of trial medication. Adequate contraception is\r<br> defined as two barrier methods, or one barrier method with spermicide, or an\r<br> intrauterine device, or use of a combined oral female hormonal contraceptive (or\r<br> the definitions requested by health authorities and locally amended in the core\r<br> study 28063). For the purposes of this trial, women of childbearing potential are\r<br> defined as: \"All female subjects after puberty unless they are post-menopausal\r<br> for at least two years or are surgically sterile\" (For Germany Only: Female\r<br> subjects of childbearing potential must be willing to avoid pregnancy by using\r<br> highly effective methods of contraception for approximately four (4) weeks prior\r<br> to D1-EXT, during and for twelve (12) weeks after the last dose of trial\r<br> medication. This requirement does not apply to surgically sterile subjects or to\r<br> subjects who are postmenopausal for at least 2 years. Highly effective\r<br> contraception is defined as any method or combination of methods which result in\r<br> a low failure rate (i.e. less than (<) 1% per year) when used consistently and\r<br> correctly, such as implants, injectables, combined oral contraceptives, sexual\r<br> abstinence, vasectomized partner, 2 barrier methods, or 1 barrier method with\r<br> spermicide)\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - To be eligible for treatment with investigational medicinal product (IMP) in study\r<br> 28851, the subjects must not meet any of the following criteria:\r<br>\r<br> - Non-eligibility for participation in extension study 28851 (premature discontinuation\r<br> of core study 28063).\r<br>\r<br> - Major protocol violation or non-compliance in the core study.\r<br>\r<br> - Use of prohibited immunomodulatory / immunosuppressive therapies\r<br>\r<br> - Serum immunoglobulin G (IgG) level <3 gram per liter (g/L) if the subject received\r<br> atacicept in the core study, or serum IgG level <6 g/L if the subject received placebo\r<br> in the core study (to protect the blinding of the core study, the IgG level will be\r<br> communicated to the treating physician only if it is too low for extension study\r<br> participation and only after all Week 36 assessments performed within the core study\r<br> have been completed).\r<br>\r<br> - Any condition, including laboratory findings that, in the opinion of the Investigator,\r<br> constitutes a risk or a contraindication for participation in the extension study, or\r<br> that could interfere with the study objectives, conduct or evaluation.\r<br>\r<br> - Known active clinically significant acute or chronic infection, or any major episode\r<br> of infection requiring hospitalization or treatment with parenteral anti-infectives.\r<br>\r<br> - Investigator judgement that treatment of the subject with atacicept in the extension\r<br> study is not appropriate.\r<br>\r<br> - Aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or alkaline\r<br> phosphatase (AP) level greater than (>)2.5 x upper limit of normal (ULN), or total\r<br> bilirubin >1.5 x ULN at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality in any hematological test (e.g. hemoglobin <100 g/L\r<br> (6.21 millimoles per liter [mmol/L]), white blood cells <3 x 10^9 per liter (/L),\r<br> platelets <100 x 10^9/L) at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality on electrocardiogram (ECG) performed at eligibility\r<br> assessment.\r<br>\r<br> - Presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive\r<br> heart failure at Week 36 of the core study.\r<br>\r<br> - Moderate to severe renal impairment (creatinine clearance <50 milliliter per minute\r<br> (mL/min) according to Cockcroft-Gault equation).\r<br>\r<br> - Allergy or hypersensitivity to gadolinium (Gd).\r<br>\r<br> - Allergy or hypersensitivity to atacicept or to any of the components of the formulated\r<br> atacicept.\r<br>\r<br> - Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Participation in study 28063.\r<br>\r<br> - Completion of Week 36 visit of the core study 28063.\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - Voluntary provision of written informed consent (including, for the USA, subject\r<br> authorization under the Health Insurance Portability and Accountability Act (HIPAA)),\r<br> given before any study-related procedure that is not part of normal medical care and\r<br> with the understanding that the subject may withdraw consent at any time without\r<br> prejudice to his or her future medical care.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Premature discontinuation of core study 28063.\r<br>\r<br> - Subjects who meet criteria listed below will receive IMP in study 28851:\r<br>\r<br> - Subjects who are eligible for participation in extension study 28851 but do not\r<br> meet these criteria will not be treated with IMP but will undergo scheduled\r<br> visits, irrespective of their treatment.\r<br>\r<br> - All subjects must satisfy the following criteria before Extension Study Day 1 (D1-EXT;\r<br> defined as the first day of dosing in the extension study) to be eligible for\r<br> treatment with IMP:\r<br>\r<br> - Eligibility for participation in extension study 28851.\r<br>\r<br> - For women of childbearing potential, a negative urine pregnancy test at\r<br> eligibility assessment.\r<br>\r<br> - Female subjects of childbearing potential must be willing to avoid pregnancy by\r<br> using an adequate method of contraception for four (4) weeks before the first\r<br> dose administered within the extension study, during the study and for twelve\r<br> (12) weeks after the last dose of trial medication. Adequate contraception is\r<br> defined as two barrier methods, or one barrier method with spermicide, or an\r<br> intrauterine device, or use of a combined oral female hormonal contraceptive (or\r<br> the definitions requested by health authorities and locally amended in the core\r<br> study 28063). For the purposes of this trial, women of childbearing potential are\r<br> defined as: \"All female subjects after puberty unless they are post-menopausal\r<br> for at least two years or are surgically sterile\" (For Germany Only: Female\r<br> subjects of childbearing potential must be willing to avoid pregnancy by using\r<br> highly effective methods of contraception for approximately four (4) weeks prior\r<br> to D1-EXT, during and for twelve (12) weeks after the last dose of trial\r<br> medication. This requirement does not apply to surgically sterile subjects or to\r<br> subjects who are postmenopausal for at least 2 years. Highly effective\r<br> contraception is defined as any method or combination of methods which result in\r<br> a low failure rate (i.e. less than (<) 1% per year) when used consistently and\r<br> correctly, such as implants, injectables, combined oral contraceptives, sexual\r<br> abstinence, vasectomized partner, 2 barrier methods, or 1 barrier method with\r<br> spermicide)\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - To be eligible for treatment with investigational medicinal product (IMP) in study\r<br> 28851, the subjects must not meet any of the following criteria:\r<br>\r<br> - Non-eligibility for participation in extension study 28851 (premature discontinuation\r<br> of core study 28063).\r<br>\r<br> - Major protocol violation or non-compliance in the core study.\r<br>\r<br> - Use of prohibited immunomodulatory / immunosuppressive therapies\r<br>\r<br> - Serum immunoglobulin G (IgG) level <3 gram per liter (g/L) if the subject received\r<br> atacicept in the core study, or serum IgG level <6 g/L if the subject received placebo\r<br> in the core study (to protect the blinding of the core study, the IgG level will be\r<br> communicated to the treating physician only if it is too low for extension study\r<br> participation and only after all Week 36 assessments performed within the core study\r<br> have been completed).\r<br>\r<br> - Any condition, including laboratory findings that, in the opinion of the Investigator,\r<br> constitutes a risk or a contraindication for participation in the extension study, or\r<br> that could interfere with the study objectives, conduct or evaluation.\r<br>\r<br> - Known active clinically significant acute or chronic infection, or any major episode\r<br> of infection requiring hospitalization or treatment with parenteral anti-infectives.\r<br>\r<br> - Investigator judgement that treatment of the subject with atacicept in the extension\r<br> study is not appropriate.\r<br>\r<br> - Aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or alkaline\r<br> phosphatase (AP) level greater than (>)2.5 x upper limit of normal (ULN), or total\r<br> bilirubin >1.5 x ULN at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality in any hematological test (e.g. hemoglobin <100 g/L\r<br> (6.21 millimoles per liter [mmol/L]), white blood cells <3 x 10^9 per liter (/L),\r<br> platelets <100 x 10^9/L) at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality on electrocardiogram (ECG) performed at eligibility\r<br> assessment.\r<br>\r<br> - Presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive\r<br> heart failure at Week 36 of the core study.\r<br>\r<br> - Moderate to severe renal impairment (creatinine clearance <50 milliliter per minute\r<br> (mL/min) according to Cockcroft-Gault equation).\r<br>\r<br> - Allergy or hypersensitivity to gadolinium (Gd).\r<br>\r<br> - Allergy or hypersensitivity to atacicept or to any of the components of the formulated\r<br> atacicept.\r<br>\r<br> - Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Participation in study 28063.\r<br>\r<br> - Completion of Week 36 visit of the core study 28063.\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - Voluntary provision of written informed consent (including, for the USA, subject\r<br> authorization under the Health Insurance Portability and Accountability Act (HIPAA)),\r<br> given before any study-related procedure that is not part of normal medical care and\r<br> with the understanding that the subject may withdraw consent at any time without\r<br> prejudice to his or her future medical care.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Premature discontinuation of core study 28063.\r<br>\r<br> - Subjects who meet criteria listed below will receive IMP in study 28851:\r<br>\r<br> - Subjects who are eligible for participation in extension study 28851 but do not\r<br> meet these criteria will not be treated with IMP but will undergo scheduled\r<br> visits, irrespective of their treatment.\r<br>\r<br> - All subjects must satisfy the following criteria before Extension Study Day 1 (D1-EXT;\r<br> defined as the first day of dosing in the extension study) to be eligible for\r<br> treatment with IMP:\r<br>\r<br> - Eligibility for participation in extension study 28851.\r<br>\r<br> - For women of childbearing potential, a negative urine pregnancy test at\r<br> eligibility assessment.\r<br>\r<br> - Female subjects of childbearing potential must be willing to avoid pregnancy by\r<br> using an adequate method of contraception for four (4) weeks before the first\r<br> dose administered within the extension study, during the study and for twelve\r<br> (12) weeks after the last dose of trial medication. Adequate contraception is\r<br> defined as two barrier methods, or one barrier method with spermicide, or an\r<br> intrauterine device, or use of a combined oral female hormonal contraceptive (or\r<br> the definitions requested by health authorities and locally amended in the core\r<br> study 28063). For the purposes of this trial, women of childbearing potential are\r<br> defined as: \"All female subjects after puberty unless they are post-menopausal\r<br> for at least two years or are surgically sterile\" (For Germany Only: Female\r<br> subjects of childbearing potential must be willing to avoid pregnancy by using\r<br> highly effective methods of contraception for approximately four (4) weeks prior\r<br> to D1-EXT, during and for twelve (12) weeks after the last dose of trial\r<br> medication. This requirement does not apply to surgically sterile subjects or to\r<br> subjects who are postmenopausal for at least 2 years. Highly effective\r<br> contraception is defined as any method or combination of methods which result in\r<br> a low failure rate (i.e. less than (<) 1% per year) when used consistently and\r<br> correctly, such as implants, injectables, combined oral contraceptives, sexual\r<br> abstinence, vasectomized partner, 2 barrier methods, or 1 barrier method with\r<br> spermicide)\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - To be eligible for treatment with investigational medicinal product (IMP) in study\r<br> 28851, the subjects must not meet any of the following criteria:\r<br>\r<br> - Non-eligibility for participation in extension study 28851 (premature discontinuation\r<br> of core study 28063).\r<br>\r<br> - Major protocol violation or non-compliance in the core study.\r<br>\r<br> - Use of prohibited immunomodulatory / immunosuppressive therapies\r<br>\r<br> - Serum immunoglobulin G (IgG) level <3 gram per liter (g/L) if the subject received\r<br> atacicept in the core study, or serum IgG level <6 g/L if the subject received placebo\r<br> in the core study (to protect the blinding of the core study, the IgG level will be\r<br> communicated to the treating physician only if it is too low for extension study\r<br> participation and only after all Week 36 assessments performed within the core study\r<br> have been completed).\r<br>\r<br> - Any condition, including laboratory findings that, in the opinion of the Investigator,\r<br> constitutes a risk or a contraindication for participation in the extension study, or\r<br> that could interfere with the study objectives, conduct or evaluation.\r<br>\r<br> - Known active clinically significant acute or chronic infection, or any major episode\r<br> of infection requiring hospitalization or treatment with parenteral anti-infectives.\r<br>\r<br> - Investigator judgement that treatment of the subject with atacicept in the extension\r<br> study is not appropriate.\r<br>\r<br> - Aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or alkaline\r<br> phosphatase (AP) level greater than (>)2.5 x upper limit of normal (ULN), or total\r<br> bilirubin >1.5 x ULN at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality in any hematological test (e.g. hemoglobin <100 g/L\r<br> (6.21 millimoles per liter [mmol/L]), white blood cells <3 x 10^9 per liter (/L),\r<br> platelets <100 x 10^9/L) at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality on electrocardiogram (ECG) performed at eligibility\r<br> assessment.\r<br>\r<br> - Presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive\r<br> heart failure at Week 36 of the core study.\r<br>\r<br> - Moderate to severe renal impairment (creatinine clearance <50 milliliter per minute\r<br> (mL/min) according to Cockcroft-Gault equation).\r<br>\r<br> - Allergy or hypersensitivity to gadolinium (Gd).\r<br>\r<br> - Allergy or hypersensitivity to atacicept or to any of the components of the formulated\r<br> atacicept.\r<br>\r<br> - Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).\r<br>", "exclusion_criteria": null, "condition": "Relapsing Multiple Sclerosis;Relapsing Multiple Sclerosis;Relapsing Multiple Sclerosis;Relapsing Multiple Sclerosis", "intervention": "Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Drug: Atacicept 150 mg;Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Drug: Atacicept 150 mg;Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Drug: Atacicept 150 mg;Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Drug: Atacicept 150 mg", "primary_outcome": "Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity;Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP);Change From Baseline in Vital Signs: Pulse Rate;Change From Baseline in Vital Signs: Temperature;Change From Baseline in Electrocardiogram (ECGs);Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels;Number of Subjects With Positive Neutralizing Antibody (NAb);Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity;Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP);Change From Baseline in Vital Signs: Pulse Rate;Change From Baseline in Vital Signs: Temperature;Change From Baseline in Electrocardiogram (ECGs);Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels;Number of Subjects With Positive Neutralizing Antibody (NAb);Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity;Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP);Change From Baseline in Vital Signs: Pulse Rate;Change From Baseline in Vital Signs: Temperature;Change From Baseline in Electrocardiogram (ECGs);Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels;Number of Subjects With Positive Neutralizing Antibody (NAb)", "secondary_outcome": "Number of Subjects With Clinical Attacks/Relapses;Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12;Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12;Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject;Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions (New or Enlarging T2 Lesions) Per Subject;Concentrations of Free and Total Atacicept;Free B-Lymphocyte Stimulator (BLyS) and Free A Proliferation-Inducing Ligand (APRIL) Serum Concentrations.;Pharmacogenetics/Pharmacogenomics Analysis", "secondary_id": "28851", "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": 3580, "title": "Low Fat Diet and Multiple Sclerosis", "summary": null, "published_date": "2009-02-26T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.417726Z", "link": "http://clinicaltrials.gov/show/NCT00852722", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00852722" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4654684", "last_refreshed_on": "2015-02-19", "scientific_title": "A Randomized, Controlled Study of Diet and Multiple Sclerosis", "primary_sponsor": "Oregon Health and Science University", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "Both", "date_enrollement": "2009-02-19", "target_size": "61", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 1", "countries": "United States", "contact_firstname": "", "contact_lastname": "Vijayshree Yadav, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Oregon Health and Science University", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Clinical diagnosis of the relapsing-remitting form of MS\r<br>\r<br> - Age 18-70, inclusive\r<br>\r<br> - MS duration of less than 15 years\r<br>\r<br> - May or may not be on disease-modifying therapies for MS, but if on, must be on for\r<br> more than 6 months of continuous therapy\r<br>\r<br> - Should not have diabetes\r<br>\r<br> - Able and willing to follow exercise instructions\r<br>\r<br> - Able and willing to travel to California for 10-day training program (cost covered by\r<br> study)\r<br>\r<br> - Able and willing to travel to Portland, OR for 6 study visits over the 12 month study\r<br> period (cost covered by study)\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - No clinically significant MS exacerbation within 30 days of screening visit\r<br>\r<br> - No systemically administered corticosteroids within 30 days of study entry\r<br>\r<br> - Patient not pregnant or breastfeeding\r<br>\r<br> - Not taking fish oil/flax seed for at least 2 months prior to first visit\r<br>\r<br> - No other significant health programs (e.g. active coronary heart disease, liver\r<br> disease, pulmonary disease) that might increase risk of patient experiencing adverse\r<br> events\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Low fat study diet", "primary_outcome": "Number of new MS T2 lesion formation on brain MRI in those randomized to the low fat study diet with that of subjects randomized to follow their regular diet.", "secondary_outcome": "To assess effects of the low fat study diet on clinical activity of MS as by relapse rate and disability progression and on fatigue, depression and quality of life.;To study the effects of the Low Fat Study Diet on serum markers of inflammation;To assess safety and tolerability of the low fat study diet upon 12 months of administration", "secondary_id": "OHSU IRB00004555", "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": 3579, "title": "Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis", "summary": null, "published_date": "2009-02-27T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.393983Z", "link": "http://clinicaltrials.gov/show/NCT00854750", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00854750" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4654839", "last_refreshed_on": "2015-02-19", "scientific_title": "Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis", "primary_sponsor": "Elliot Frohman", "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": "2009-05-19", "target_size": "1", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment", "phase": "Phase 4", "countries": "United States", "contact_firstname": "", "contact_lastname": "Elliot Frohman, MD, PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "UT Southwestern Medical Center", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Subject has clinically or laboratory supported Multiple Sclerosis with evidence of\r<br> INO by quantitative neurophysiologic criteria or has a history of ON.\r<br>\r<br> 2. Subject is between the ages of 18-65.\r<br>\r<br> 3. Subject is able to understand the demands of the protocol, has had any questions\r<br> answered and has voluntarily signed the informed consent prior to any study\r<br> procedures.\r<br>\r<br> 4. Subject has a peak saccadic acceleration ratio (abducting eye/adducting eye) of\r<br> greater than 2S.D. above the mean derived form a normal control group.\r<br>\r<br> 5. Subject is otherwise in good health, based on complete medical history and physical\r<br> examination, including vital signs and ECG.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Subject is a pregnant female (as determined by a urine pregnancy test), a lactating\r<br> female, or a female of child-bearing potential, not sterilized and not using one of\r<br> the following methods of birth control: oral or injectable contraceptive agent,\r<br> implantable contraceptive device, or barrier method.\r<br>\r<br> 2. Subject has a history of hypertension or diabetes.\r<br>\r<br> 3. Subject has known allergy to ACTH.\r<br>\r<br> 4. The subject has any medical condition, including psychiatric disease that might\r<br> interfere with the interpretation of the results or with the conduct of the study.\r<br>\r<br> 5. Subject has a history of drug or ethanol abuse within the past year.\r<br>\r<br> 6. Subject has a history of ischemic heart disease.\r<br>\r<br> 7. Subject has received an investigational drug within 30 days of screening.\r<br>\r<br> 8. In opinion of investigator, subject is unlikely to complete study for any reason.\r<br>\r<br> 9. The subject has abnormal clinical laboratory values or an abnormal ECG, without\r<br> approval of the study monitor.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: ACTHAR;Drug: ACTHAR;Drug: ACTHAR;Drug: ACTHAR", "primary_outcome": "To determine if preemptive cooling provides protection against worsening of INO and its effect on reading, with body heating.", "secondary_outcome": "To determine whether changes in core body temperature has an impact on patient reported measures of vision (high and low contrast acuity) and reading acuity and speed.", "secondary_id": "ACTHAR version 1.0", "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": 3578, "title": "Expiratory Muscle Training for Persons With Neurodegenerative Disease", "summary": null, "published_date": "2009-03-03T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.373443Z", "link": "https://clinicaltrials.gov/show/NCT00856518", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00856518" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6493272", "last_refreshed_on": "2017-10-19", "scientific_title": "Expiratory Muscle Training for Persons With Neurodegenerative Disease", "primary_sponsor": "VA Office of Research and Development", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "35 Years", "inclusion_agemax": "80 Years", "inclusion_gender": "All", "date_enrollement": "2009-03-19", "target_size": "42", "study_type": "Interventional", "study_design": null, "phase": "Phase 2/Phase 3", "countries": "United States;United States;United States;United States", "contact_firstname": "; ; ;", "contact_lastname": "Janis J. Daly, PhD MS;Janis J. Daly, PhD MS;Janis J. Daly, PhD MS;Janis J. Daly, PhD MS", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "North Florida/South Georgia Veterans Health System, Gainesville, FL;North Florida/South Georgia Veterans Health System, Gainesville, FL;North Florida/South Georgia Veterans Health System, Gainesville, FL;North Florida/South Georgia Veterans Health System, Gainesville, FL", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Multiple Sclerosis Participants\r<br>\r<br> - Diagnosis of primary, secondary, or relapsing-remitting MS by a neurologist\r<br>\r<br> - Over 85% of the patient populations that come from the study sites demonstrate\r<br> relapsing-remitting MS with an average relapse frequency of once every 3 years\r<br>\r<br> Parkinson's Disease Participants\r<br>\r<br> - Hoehn & Yahr, stage II and III as indicated by certified movement disorders\r<br> neurologist\r<br>\r<br> All Participants\r<br>\r<br> - Between 35 and 80 years of age\r<br>\r<br> - Non-smoking or no smoking within the previous five years\r<br>\r<br> - No history of head and neck cancer, asthma or COPD, untreated hypertension\r<br>\r<br> - Sufficient facial muscle strength so as to achieve and maintain adequate lip closure\r<br> around a circular mouthpiece\r<br>\r<br> - Cognition within normal limits as determined by the: Mini Mental Status Exam (MMSE;\r<br> 1975No neurological (other than MS or PD) condition which adversely affects\r<br> respiratory muscle or gas exchange system\r<br>\r<br> - Reduced MEP's compared to published normative data for age and sex\r<br>\r<br> - Reduced expiratory peak flow rates (6-8 L/s for young to middle age adults and 3.6 L/s\r<br> for 65 and older) during voluntary cough production for age and sex (Bolser, personal\r<br> communication; Smith-Hammond & Goldstein, 2006)\r<br>\r<br> - Participant report of symptoms related to swallow impairment\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - DBS\r<br>\r<br> - COPD\r<br>\r<br> - Asthma\r<br>\r<br> - Smoking or smoking within preceding 5 years\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Multiple Sclerosis Participants\r<br>\r<br> - Diagnosis of primary, secondary, or relapsing-remitting MS by a neurologist\r<br>\r<br> - Over 85% of the patient populations that come from the study sites demonstrate\r<br> relapsing-remitting MS with an average relapse frequency of once every 3 years\r<br>\r<br> Parkinson's Disease Participants\r<br>\r<br> - Hoehn & Yahr, stage II and III as indicated by certified movement disorders\r<br> neurologist\r<br>\r<br> All Participants\r<br>\r<br> - Between 35 and 80 years of age\r<br>\r<br> - Non-smoking or no smoking within the previous five years\r<br>\r<br> - No history of head and neck cancer, asthma or COPD, untreated hypertension\r<br>\r<br> - Sufficient facial muscle strength so as to achieve and maintain adequate lip closure\r<br> around a circular mouthpiece\r<br>\r<br> - Cognition within normal limits as determined by the: Mini Mental Status Exam (MMSE;\r<br> 1975No neurological (other than MS or PD) condition which adversely affects\r<br> respiratory muscle or gas exchange system\r<br>\r<br> - Reduced MEP's compared to published normative data for age and sex\r<br>\r<br> - Reduced expiratory peak flow rates (6-8 L/s for young to middle age adults and 3.6 L/s\r<br> for 65 and older) during voluntary cough production for age and sex (Bolser, personal\r<br> communication; Smith-Hammond & Goldstein, 2006)\r<br>\r<br> - Participant report of symptoms related to swallow impairment\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - DBS\r<br>\r<br> - COPD\r<br>\r<br> - Asthma\r<br>\r<br> - Smoking or smoking within preceding 5 years\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Multiple Sclerosis Participants\r<br>\r<br> - Diagnosis of primary, secondary, or relapsing-remitting MS by a neurologist\r<br>\r<br> - Over 85% of the patient populations that come from the study sites demonstrate\r<br> relapsing-remitting MS with an average relapse frequency of once every 3 years\r<br>\r<br> Parkinson's Disease Participants\r<br>\r<br> - Hoehn & Yahr, stage II and III as indicated by certified movement disorders\r<br> neurologist\r<br>\r<br> All Participants\r<br>\r<br> - Between 35 and 80 years of age\r<br>\r<br> - Non-smoking or no smoking within the previous five years\r<br>\r<br> - No history of head and neck cancer, asthma or COPD, untreated hypertension\r<br>\r<br> - Sufficient facial muscle strength so as to achieve and maintain adequate lip closure\r<br> around a circular mouthpiece\r<br>\r<br> - Cognition within normal limits as determined by the: Mini Mental Status Exam (MMSE;\r<br> 1975No neurological (other than MS or PD) condition which adversely affects\r<br> respiratory muscle or gas exchange system\r<br>\r<br> - Reduced MEP's compared to published normative data for age and sex\r<br>\r<br> - Reduced expiratory peak flow rates (6-8 L/s for young to middle age adults and 3.6 L/s\r<br> for 65 and older) during voluntary cough production for age and sex (Bolser, personal\r<br> communication; Smith-Hammond & Goldstein, 2006)\r<br>\r<br> - Participant report of symptoms related to swallow impairment\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - DBS\r<br>\r<br> - COPD\r<br>\r<br> - Asthma\r<br>\r<br> - Smoking or smoking within preceding 5 years\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Multiple Sclerosis Participants\r<br>\r<br> - Diagnosis of primary, secondary, or relapsing-remitting MS by a neurologist\r<br>\r<br> - Over 85% of the patient populations that come from the study sites demonstrate\r<br> relapsing-remitting MS with an average relapse frequency of once every 3 years\r<br>\r<br> Parkinson's Disease Participants\r<br>\r<br> - Hoehn & Yahr, stage II and III as indicated by certified movement disorders\r<br> neurologist\r<br>\r<br> All Participants\r<br>\r<br> - Between 35 and 80 years of age\r<br>\r<br> - Non-smoking or no smoking within the previous five years\r<br>\r<br> - No history of head and neck cancer, asthma or COPD, untreated hypertension\r<br>\r<br> - Sufficient facial muscle strength so as to achieve and maintain adequate lip closure\r<br> around a circular mouthpiece\r<br>\r<br> - Cognition within normal limits as determined by the: Mini Mental Status Exam (MMSE;\r<br> 1975No neurological (other than MS or PD) condition which adversely affects\r<br> respiratory muscle or gas exchange system\r<br>\r<br> - Reduced MEP's compared to published normative data for age and sex\r<br>\r<br> - Reduced expiratory peak flow rates (6-8 L/s for young to middle age adults and 3.6 L/s\r<br> for 65 and older) during voluntary cough production for age and sex (Bolser, personal\r<br> communication; Smith-Hammond & Goldstein, 2006)\r<br>\r<br> - Participant report of symptoms related to swallow impairment\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - DBS\r<br>\r<br> - COPD\r<br>\r<br> - Asthma\r<br>\r<br> - Smoking or smoking within preceding 5 years\r<br>", "exclusion_criteria": null, "condition": "Parkinson's Disease;Multiple Sclerosis;Parkinson's Disease;Multiple Sclerosis;Parkinson's Disease;Multiple Sclerosis;Parkinson's Disease;Multiple Sclerosis", "intervention": "Device: EMST;Device: Sham;Device: EMST;Device: Sham;Device: EMST;Device: Sham;Device: EMST;Device: Sham", "primary_outcome": "Maximum Expiratory Pressure (MEP);Penetration-Aspiration Scale Score;Swallow-related Quality of Life (SWAL-QOL);Maximum Expiratory Pressure (MEP);Penetration-Aspiration Scale Score;Swallow-related Quality of Life (SWAL-QOL)", "secondary_outcome": null, "secondary_id": "B6576-R", "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": 3577, "title": "A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase", "summary": null, "published_date": "2009-03-03T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.351029Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007015-32", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-007015-32-DE" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "3200942", "last_refreshed_on": "2013-03-11", "scientific_title": "A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase", "primary_sponsor": "Novartis Pharma GmbH", "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": null, "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": "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)\tWritten informed consent to participate in the trial\t<br>2)\tMales and females between 18 and 55 years of age;<br>3)\tDefinite diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria (Appendix 4) <br>4)\tMS-subtype: CIS, RRMS, SPMS;<br>6)\tStable and well tolerated therapy with interferon beta-1b (Extavia®) for at least 60 days immediately prior to baseline. This period does not apply to patients swithed directly from Betaferon.<br>7)\tCognitive Impairment defined as FST score of =3.0 and/or MUSIC score of =19 at screening<br>8)\tVerbal memory impairment defined as a score =0.5 standard deviations (SD) below age- and sex-based normative data on the RAVLT score at screening<br>9)\tSufficient education to read, write and communicate comprehensibly<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.\tUse of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer<br>2.\tPatient with advanced disease serious enough to, under the judgment of the physician-investigator, place the patient at a special risk situation. <br>3.\tWomen<br>o\twho are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))<br>o\twho are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception <br>4.\tWith a physical or sensory disability that can subjectively prevent the patient from completing all study requirements <br>5.\tPatients without contractual capability.<br>6.\tPatients suffering any other type of concomitant psychiatric and/or neurological disorder other than MS which is known to affect cognition (e.g. severe depressive symptoms, cerebrovascular diseases, epilepsy).<br>7.\tPatients suffering an acute relapse of MS in the previous 30 days (treated or not with intravenous or oral glucocorticoid regimens) prior to baseline.<br>8.\tPatients on any other treatment for MS than described in inclusion criteria<br>9.\tWith a history or current problem of drug-addiction and/or alcohol abuse.<br>10.\tCurrent or historical laboratory evidence of vitamin B1 and/or vitamin B12 deficit<br>11.\tKnown or ‘new’ diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [=126 mg/dL or =7 mmol/L if fasting and =200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)<br>12.\tAny of the following hepatic conditions:<br>•\ttotal or conjugated bilirubin greater than 2 times the upper limit of the normal range, unless in context of Gilbert’s syndrome<br>•\tAST (=SGOT), ALT (=SGPT) greater than 3 times the upper limit of the normal range <br>13.\tWith any of the following abnormal laboratory values at screening:<br>•\tserum creatinine >2 ULN or a history of hemodialysis<br>•\twhite blood cell (WBC) count <3,500/mm³ (<3.5 x 109 / L)<br>•\tSerum electrolyte, BUN and Thyroidea stimulating hormone (TSH) concentrations outside the range as specified also in Appendix 2. <br>14.\tWith a history of severe or moderate-severe cranioencephalic trauma. <br>15.\tStudy personnel or first degree relatives of investigator(s) must not be included in the study<br>16.\tHistory or presence of any intolerance or contraindication for the application of rivastigmine (or for drugs with similar chemical structures) as listed in the current Investigator’s Brochure and/or SPC, i.e. severe liver insufficiency, pancreatitis, gastric ulcer, convulsions.<br>17.\tPatients with any of the following diseases serious or unstable: gastrointestinal disease; clinically significant urinary obstruction under clinical judgement; acute, severe or unstable asthmatic conditions [for instance, severe chronic obstructive pulmonary disease (COPD)]; current and known diagnosis of severe or unstable cardiovascular disease; current and known diagnosis of bradycardia (? 40 bpm), sinus syndrome or conductivity disorders (atrial sinus blockage, 2nd or 3rd degree atrioventricular block).<br>18.\tWith a history in the past year or a current diagnosis of cerebrovascular disease (for instance, stroke, transient ischemic events, aneurysms).<br>19.\tSevere depressive symptoms indicated by a score of more than = 14 on the MADRS at screening<br>20.\tPatients who have performed a cognitive testing with Brief rep", "condition": "cognitive impairment in Multiple Sclerosis <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10028245\nTerm: Multiple sclerosis", "intervention": "<br>Trade Name: Exelon transdermales Pflaster<br>Product Name: Exelon<br>Product Code: ENA713<br>Pharmaceutical Form: Transdermal patch<br>INN or Proposed INN: Rivastigmin<br>CAS Number: 123441-03-2<br>Current Sponsor code: ENA713<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 9-<br>Pharmaceutical form of the placebo: Transdermal patch<br>Route of administration of the placebo: Transdermal use<br><br>Trade Name: Exelon transdermales Pflaster<br>Product Name: Exelon<br>Product Code: ENA713<br>Pharmaceutical Form: Transdermal patch<br>INN or Proposed INN: Rivastigmin<br>CAS Number: 123441-03-2<br>Current Sponsor code: ENA713<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 18-<br>Pharmaceutical form of the placebo: Transdermal patch<br>Route of administration of the placebo: Transdermal use<br><br>Trade Name: Exelon transdermales Pflaster<br>Product Name: Exelon<br>Product Code: ENA713<br>Pharmaceutical Form: Transdermal patch<br>INN or Proposed INN: Rivastigmin<br>CAS Number: 123441-03-2<br>Current Sponsor code: ENA713<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 9-<br><br>Trade Name: Exelon transdermales Pflaster<br>Product Name: Exelon<br>Product Code: ENA713<br>Pharmaceutical Form: Transdermal patch<br>INN or Proposed INN: Rivastigmin<br>CAS Number: 123441-03-2<br>Current Sponsor code: ENA713<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 18-<br><br>", "primary_outcome": "Main Objective: To demonstrate that rivastigmine patch (target patch size 10 cm²) has superior efficacy compared to placebo on a change from baseline of the total recall score of the selective reminding test (SRT) of the Brief Repeatable Battery of Neuropsychological Tests (BRB-N) in cognitive impaired MS patients after 16 weeks of treatment.;Secondary Objective: ? effect on different cognitive domains <br>? effect on fatigue in MS-patients treated with rivastigmine patch versus Placebo, the Modified Fatigue Impact Scale (mFIS) will be used after 16 weeks of treatment<br>? effect on depression in MS-patients <br>? effect on the course of disease in MS- patients, the multiple sclerosis functional composite (MSFC) will be used after 16 weeks of treatment<br>? effect on quality of life in MS-patients treated with rivastigmine patch versus Placebo, the QOL subscale of the PRIMuS will be used after 16 weeks of treatment<br>? safety and tolerability in MS patients up to 68 weeks of treatment<br>? the longterm effect on all primary and secondary objectives listed above, the BRB-N, PRIMuS, CGI, mFIS, MADRS and MSFC will be used after 32 and 68 weeks of treatment<br>? longitudinal measurement of screening instruments, the Faces Symbol Test (FST) will be used and compared with BRB after 16, 32 and 68 weeks of treatment;Primary end point(s): The primary endpoint is the change in score of total recall on the SRT (baseline to week 16). The SRT is a widely used measure of verbal learning and memory that is part of the Brief Repeatable Battery of Neuropsychological Test in MS (BRB-N).", "secondary_outcome": null, "secondary_id": "CENA713DDE18", "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": 3576, "title": "Differential Immune Effects of Natalizumab", "summary": null, "published_date": "2009-10-03T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.330745Z", "link": "http://clinicaltrials.gov/show/NCT00859482", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00859482" }, "categories": [ { "category_id": 7, "category_description": "", "category_name": "Natalizumab", "category_slug": "natalizumab", "category_terms": [ "natalizumab", "tysabri" ], "article_count": 298 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4655196", "last_refreshed_on": "2015-02-19", "scientific_title": "A Phase IV Study to Investigate Differential Immune Effects of Natalizumab", "primary_sponsor": "Cantonal Hospital of St. Gallen", "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": "2006-07-19", "target_size": "27", "study_type": "Observational", "study_design": "Observational Model: Cohort, Time Perspective: Prospective", "phase": "N/A", "countries": null, "contact_firstname": "", "contact_lastname": "Norman Putzki, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "KSSG, 9007 St. Gallen, Switzerland", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - relapsing remitting MS\r<br>\r<br> - indication for natalizumab treatment\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - other disease modifying agents within 2 weeks\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis, Relapsing Remitting", "intervention": null, "primary_outcome": "Function of T regulatory cells", "secondary_outcome": "Change in distinct immune cell lines", "secondary_id": "Ntz-Tregs1", "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": 3575, "title": "Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy", "summary": null, "published_date": "2009-12-03T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.308671Z", "link": "http://clinicaltrials.gov/show/NCT00861172", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00861172" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4655324", "last_refreshed_on": "2015-02-19", "scientific_title": "Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy", "primary_sponsor": "Hospices Civils de Lyon", "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": "2009-02-19", "target_size": "6", "study_type": "Interventional", "study_design": "Intervention Model: Single Group Assignment, Masking: Open Label", "phase": "N/A", "countries": "France", "contact_firstname": "", "contact_lastname": "Francois Cotton, Pr", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Hospices Civils de Lyon", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Age between 18 and 50 years.\r<br>\r<br> - Health coverage.\r<br>\r<br> - Any form of MS defined by Mc Donald's criteria (2005).\r<br>\r<br> - Patients having shown an enhanced plaque on a less than six month MRI examination.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients with an immunomodulating therapy like natalizumab (Tysabri) and intravenous\r<br> immunosuppressive therapies. Other therapies will not be excluded from this study.\r<br> For patients treated by systemic corticotherapy, a one-month delay will be necessary\r<br> before a MRI examination.\r<br>\r<br> - Cerebral microangiopathy (diabetes, arterial hypertension, vascularitis…)\r<br>\r<br> - Patient with classical MRI contraindication like pace-maker, cardiac valvulosis,\r<br> claustrophobia, allergy to contrast agent …\r<br>\r<br> - Pregnancy or pregnancy desire.\r<br>\r<br> - Patient with a low creatinine clearance <60 ml/mn\r<br>", "exclusion_criteria": null, "condition": "Lesions;Multiple Sclerosis", "intervention": "Procedure: 3T MR scanner", "primary_outcome": "Modification of MR parameters before and after the blood brain barrier disruption observed in newly enhancing lesion in MS.", "secondary_outcome": "Predictive scorers of plaque transformation in \"black-holes\", which correspond with a pejorative evolution of accurate lesions, also defined by a focal destruction of cerebral tissue.;Relation between plaques development and cerebral venous structures.", "secondary_id": "2008.532", "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 } ] }