Trials / Completed
CompletedNCT00451451
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,417 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BG00012 | |
| DRUG | Placebo | |
| DRUG | Glatiramer Acetate |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2007-03-23
- Last updated
- 2015-01-26
- Results posted
- 2014-06-02
Locations
195 sites across 28 countries: United States, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Costa Rica, Croatia, Czechia, Estonia, France, Germany, Greece, India, Ireland, Israel, Latvia, Mexico, Moldova, New Zealand, North Macedonia, Poland, Puerto Rico, Romania, Serbia, Slovakia, Spain, Ukraine
Source: ClinicalTrials.gov record NCT00451451. Inclusion in this directory is not an endorsement.