NCT02430532

BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 58 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.

Conditions

• Multiple Sclerosis, Secondary Progressive

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	capsule
OTHER	Placebo	matched placebo capsule

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-04-30
• Last updated: 2017-04-26
• Results posted: 2017-03-27

Locations

18 sites across 6 countries: United States, Belgium, Czechia, Netherlands, Poland, Slovakia