Clinical Trial: Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Phase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Pati
Brief Summary: The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.
Detailed Summary:
Sponsor: Biogen
Current Primary Outcome: Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24) [ Time Frame: Week 24 ]
Original Primary Outcome: The primary endpoint will be the mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24) [ Time Frame: at week 24 ]
Current Secondary Outcome:
- Mean number of CUA [ Time Frame: at 4, 8, 12, 16, 20 and 24 weeks ]
- Mean number of hypointense T1 lesions [ Time Frame: at 24 weeks ]
- New Gd+ lesions [ Time Frame: at 4, 8, 12, 16, 20 and 24 weeks ]
- New/enlarging T2 lesions [ Time Frame: at 4, 8, 12, 16, 20 and 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Biogen
Dates:
Date Received: May 11, 2015
Date Started: July 2015
Date Completion: July 2020
Last Updated: December 23, 2015
Last Verified: December 2015
