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| Study 2 of 29 for search of: | Macedonia, The Former Yugoslav Republic of |
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| Sponsored by: |
Biogen Idec |
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| 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 |
|---|---|---|
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Relapsing-Remitting Multiple Sclerosis |
Drug: BG00012 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 1232 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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1: Experimental
240 mg (two 120 MG capsules) twice a day
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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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2: Experimental
240 mg (two capsules) three times a day.
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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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3: Placebo Comparator
placebo
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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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4: Active Comparator
glatiramer acetate 20 mg subcutaneous injection once a day.
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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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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| Contact: Biogen Idec Inc. | bg12studies@biogenidec.com | |
| Contact: for more information visit www.msclinicalstudies.com |
Show 209 Study Locations| Study Director: | Biogen Idec Inc., MD | Biogen Idec |
More Information
| Responsible Party: | Biogen Idec Inc. ( Biogen Idec MD ) |
| Study ID Numbers: | 109MS302 |
| Study First Received: | March 21, 2007 |
| Last Updated: | January 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00451451 |
| Health Authority: | Australia: National Health and Medical Research Council; Belgium: Directorate general for the protection of Public health: Medicines; Bulgaria: Ministry of Health; Canada: Health Canada; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Ireland: Irish Medicines Board; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Mexico: Federal Commission for Protection Against Health Risks; New Zealand: Medsafe; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Spain: Spanish Agency of Medicines; Slovakia: State Institute for Drug Control; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration; United States: Institutional Review Board |
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multiple sclerosis relapsing remitting oral |
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Copolymer 1 Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
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Pathologic Processes Immunologic Factors Immune System Diseases Physiological Effects of Drugs |
Nervous System Diseases Adjuvants, Immunologic Immunosuppressive Agents Pharmacologic Actions |
