Who is sponsoring NCT02428218?

NCT02428218 is sponsored by Biogen.

What condition does NCT02428218 study?

NCT02428218 studies Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis.

What drugs are being tested in NCT02428218?

Interventions: dimethyl fumarate, Placebo.

What is the status of NCT02428218?

NCT02428218 is currently WITHDRAWN.

Last reviewed 2016-04-11 · How we verify

A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis

NCT02428218 Phase 3 WITHDRAWN

The primary objective of the study is to assess the efficacy of oral BG00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to evaluate the safety and tolerability of BG00012 and to compare the effect of BG00012 with placebo on additional clinical and radiological measures of disease activity.

Details

Lead sponsor	Biogen
Phase	Phase 3
Status	WITHDRAWN
Start date	2016-05
Completion	2027-01

Conditions

Relapsing-Remitting Multiple Sclerosis
Relapsing Forms of Multiple Sclerosis

Interventions

dimethyl fumarate
Placebo

Primary outcomes

Time to first multiple sclerosis (MS) relapse — Up to week 104
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.