At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
dimethyl fumaratedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years
In Brief
A Phase 2 clinical trial evaluating dimethyl fumarate for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 22 participants across 12 sites in 10 countries.
Detailed Summary
The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Relapsing-Remitting
CountriesBelgium, Bulgaria, Czechia, Germany, Kuwait, Latvia, Lebanon, Poland, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartSep 2015
Primary CompletionSep 2016
TodayJul 2026
First PostedApr 7, 2015
Enrollment StartSep 30, 2015
Primary CompletionSep 23, 2016
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 11.2 years ago
Interventions
dimethyl fumaratedrug