Efficacy and Safety of BG00012 in MS
Determine the efficacy,safety, and tolerability of BG00012 in MS patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis|
- The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24.
- The secondary endpoints will include measuring the changes in MRIs from baseline until Week 24, changes in other MS measurements q12 weeks, and the annualized relapse rate and proportion of changes at Weeks 24 and 48.
|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.
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|Principal Investigator:||Ludwig Kappos, Prof||Kantonsspital Basel|
|Study Director:||Gilmore O'Neill, MB, MRCPI, MMedSc||Biogen Idec|