At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 20 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.
A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis
In Brief
A Phase 3 clinical trial evaluating dimethyl fumarate for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 20 participants across 12 sites in 10 countries.
Detailed Summary
The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).
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 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartFeb 2016
Primary CompletionSep 2018
TodayJul 2026
First PostedSep 21, 2015
Enrollment StartFeb 22, 2016
Primary CompletionSep 24, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.8 years ago
Interventions
dimethyl fumaratedrug
administered orally