BG00012 Phase 2 Combination Study in Subjects With Multiple Sclerosis (EXPLORE)
This is an open-label, multicenter, study. Subjects receiving an IFNβ (Avonex, Rebif, or Betaseron) or GA as monotherapy will be enrolled. Safety, efficacy, and pharmacodynamics (PD) will be assessed during the monotherapy period and the subsequent 6 month combination treatment period with BG00012.
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Relapsing-remitting
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNβ) or Glatiramer Acetate (GA)|
- The primary objective of the study is to evaluate the safety and tolerability of BG00012 administered in combination with IFNβ or GA in subjects with RRMS. [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
- Explore the efficacy of BG00012 in combination with IFNβ or GA. [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
- Explore the effect of combination therapy on potential biomarkers of BG00012 and neopterin for IFNβ and IFNβ with BG00012. [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
BG00012 240 mg (2 capsules) TID.
BG00012 is being investigated to determine whether it is viable agent to consider for use in combination with other MS therapies.
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