At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 20 target
Drug / intervention
BG00012 (DMF) (Tecfidera®.)drug
Likely dose
BG00012 (DMF) (Tecfidera®.) 120 mgfrom 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 of the Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers in Subjects With Secondary Progressive Multiple Sclerosis
Multiple Sclerosis Center of Northeastern New York·interventional·Posted Feb 17, 2016·Updated Mar 22, 2017
In Brief
A Phase 4 clinical trial evaluating BG00012 (DMF) (Tecfidera®.) for Multiple Sclerosis. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study is to explore whether DMF (Dimethyl Fumarate) or MMF (monomethyl fumarate) its main bioactive metabolite, is capable of entering the central nervous system in SPMS patients that are being treated with Tecfidera®. PK samples (pharmacokinetics - or the amount of study drug in blood) will be tested to compare with PK samples, the amount of study drug, in spinal fluid (CSF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
CollaboratorsBiogen
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedFeb 2016
Primary CompletionJan 2017
TodayJul 2026
First PostedFeb 17, 2016
Enrollment StartAug 1, 2015
Primary CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.4 years ago
Interventions
BG00012 (DMF) (Tecfidera®.)drug
Subjects will take DMF 120 mg BID for the first 4 weeks of treatment followed by DMF 240 mg BID for 24 weeks.