At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 218 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.
An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis
In Brief
A Phase 3 clinical trial evaluating dimethyl fumarate for Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis. Completed, enrolled 218 participants across 34 sites in 7 countries.
Detailed Summary
The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Bulgaria, Kuwait, Lithuania, Poland, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedAug 2015
Primary CompletionApr 2017
Study CompletionApr 2018
TodayJul 2026
First PostedAug 18, 2015
Enrollment StartAug 11, 2015
Primary CompletionApr 24, 2017
Study CompletionApr 23, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.9 years ago
Interventions
dimethyl fumaratedrug
Initial oral dose for 7 days with maintenance dose thereafter