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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156311
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