Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis

Define Study Investigators, Raymond Hupperts

Research output: Contribution to journalArticleAcademicpeer-review

1088 Citations (Web of Science)

Abstract

BG-12 (dimethyl fumarate) was shown to have antiinflammatory and cytoprotective properties in preclinical experiments and to result in significant reductions in disease activity on magnetic resonance imaging (MRI) in a phase 2, placebo-controlled study involving patients with relapsing-remitting multiple sclerosis.We conducted a randomized, double-blind, placebo-controlled phase 3 study involving patients with relapsing-remitting multiple sclerosis. Patients were randomly assigned to receive oral BG-12 at a dose of 240 mg twice daily, BG-12 at a dose of 240 mg three times daily, or placebo. The primary end point was the proportion of patients who had a relapse by 2 years. Other end points included the annualized relapse rate, the time to confirmed progression of disability, and findings on MRI.The estimated proportion of patients who had a relapse was significantly lower in the two BG-12 groups than in the placebo group (27% with BG-12 twice daily and 26% with BG-12 thrice daily vs. 46% with placebo, P
Original languageEnglish
Pages (from-to)1098-1107
JournalNew England Journal of Medicine
Volume367
Issue number12
DOIs
Publication statusPublished - 20 Sep 2012

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