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| Sponsor: | Biogen Idec |
|---|---|
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00168701 |
Purpose
Determine the efficacy,safety, and tolerability of BG00012 in MS patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: BG00012 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis |
| Estimated Enrollment: | 260 |
| Study Start Date: | October 2004 |
| Study Completion Date: | March 2006 |
The study will be divided into two parts: Part 1 will be a 24-week, blinded, placebo-controlled treatment phase followed by Part 2, a 24-week blinded, safety extension phase in which all subjects will receive BG00012.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
5. Must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial MRI demonstrating lesion(s) consistent with MS OR show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks.
6. Male and female subjects must be willing to take appropriate measures to prevent pregnancy.
Exclusion Criteria:
Contacts and Locations
Show 42 Study Locations| Principal Investigator: | Ludwig Kappos, Prof | Kantonsspital Basel |
| Study Director: | Gilmore O'Neill, MB, MRCPI, MMedSc | Biogen Idec |
More Information
| Study ID Numbers: | C-1900 |
| Study First Received: | September 9, 2005 |
| Last Updated: | November 14, 2007 |
| ClinicalTrials.gov Identifier: | NCT00168701 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: Medicines Evaluation Board (MEB); Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Hungary: National Institute of Pharmacy; Switzerland: Swissmedic; Turkey: Ministry of Health; Sweden: Medical Products Agency; Russia: Pharmacological Committee, Ministry of Health |
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Multiple Sclerosis MRI |
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Autoimmune Diseases Demyelinating Diseases Immune System Diseases Immunologic Factors Physiological Effects of Drugs Nervous System Diseases Dimethyl fumarate Sclerosis Multiple Sclerosis, Relapsing-Remitting |
Immunosuppressive Agents Pharmacologic Actions Multiple Sclerosis Pathologic Processes Radiation-Sensitizing Agents Therapeutic Uses Demyelinating Autoimmune Diseases, CNS Dermatologic Agents Autoimmune Diseases of the Nervous System |