NCT02683863

Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers

An Open Label Study of the Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers in Subjects With Secondary Progressive Multiple Sclerosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Multiple Sclerosis Center of Northeastern New York · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	BG00012 (DMF) (Tecfidera®.)	Subjects will take DMF 120 mg BID for the first 4 weeks of treatment followed by DMF 240 mg BID for 24 weeks.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-01-31
• Completion: 2017-01-31
• First posted: 2016-02-17
• Last updated: 2017-03-22

Locations

1 site across 1 country: United States