Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS

Completed · Phase 2

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID

NCT02410200

Run by

Biogen

People needed

22

Starts

2015-09-30

Expected to finish

2016-09-23

Last updated by the study team

2017-10-23

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Research Site — San Bernardino, California, United States
• Research Site — Ghent, Belgium
• Research Site — Sofia, Bulgaria
• Research Site — Hradec Králové, Czechia
• Research Site — München, Bavaria, Germany
• Research Site — Göttingen, Lower Saxony, Germany
• Research Site — Dasman, Kuwait City, Kuwait
• Research Site — Riga, Latvia
• Research Site — Beirut, Lebanon
• Research Site — Gdansk, Poland
• Research Site — Poznan, Poland
• Research Site — Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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