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| Sponsor: | Biogen Idec |
|---|---|
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00451451 |
Purpose
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.
Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing-remitting Multiple Sclerosis |
Drug: BG00012 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis |
| Enrollment: | 1232 |
| Study Start Date: | June 2007 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
240 mg (two 120 MG capsules) twice a day
|
Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 120 mg capsules) orally three times a day, glatiramer acetate 20 mg SC injection once a day.
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Experimental: 2
240 mg (two capsules) three times a day.
|
Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 120 mg capsules) orally three times a day, glatiramer acetate 20 mg SC injection once a day.
|
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Placebo Comparator: 3
placebo
|
Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 120 mg capsules) orally three times a day, glatiramer acetate 20 mg SC injection once a day.
|
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Active Comparator: 4
glatiramer acetate 20 mg subcutaneous injection once a day.
|
Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 120 mg capsules) orally three times a day, glatiramer acetate 20 mg SC injection once a day.
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Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Show 206 Study Locations More Information
| Responsible Party: | Biogen Idec MD, Biogen Idec Inc. |
| ClinicalTrials.gov Identifier: | NCT00451451 History of Changes |
| Other Study ID Numbers: | 109MS302 |
| Study First Received: | March 21, 2007 |
| Last Updated: | September 29, 2011 |
| Health Authority: | Romania: National Medicines Agency; France: Afssaps - French Health Products Safety Agency; United States: Institutional Review Board; Ukraine: State Pharmacological Center - Ministry of Health; Ireland: Irish Medicines Board; Mexico: Federal Commission for Protection Against Health Risks; Spain: Spanish Agency of Medicines; Estonia: The State Agency of Medicine; Bulgaria: Ministry of Health; New Zealand: Medsafe; Czech Republic: State Institute for Drug Control; Australia: National Health and Medical Research Council; Greece: National Organization of Medicines; Slovakia: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Croatia: Ministry of Health and Social Care; Canada: Health Canada; Latvia: State Agency of Medicines; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United States: Food and Drug Administration; Belgium: Directorate general for the protection of Public health: Medicines; Lithuania: State Medicine Control Agency - Ministry of Health |
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relapsing multiple sclerosis oral remitting |
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Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
Copolymer 1 Dimethyl fumarate Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Dermatologic Agents Therapeutic Uses Radiation-Sensitizing Agents |
