A Phase 3 interventional study of dimethyl fumarate and Placebo in Relapsing-Remitting Multiple Sclerosis and Relapsing Forms of Multiple Sclerosis, sponsored by Biogen. Withdrawn. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-04-13.
Sponsored by Biogen · Phase 3, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Participants will receive 120 mg capsule(s) BG00012 taken orally.
Drug: dimethyl fumarate
Participants will receive matching placebo capsule(s) taken orally.
Drug: Placebo
enteric-coated microtablets
Also known as: BG00012, DMF
enteric-coated microtablets
Time to first multiple sclerosis (MS) relapse
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.
Time frame: Up to week 104
Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to week 104
Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans
Time frame: Weeks 24, 48, 72 and 96
Number of gadolinium-enhancing Lesions
Time frame: Baseline, and weeks 24, 48, 72 and 96
Annualized MS relapse rate
Time frame: weeks 48 and 96
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Biogen