NCT00420212

Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,234 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse. The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	BG00012
DRUG	Placebo

Timeline

• Start date: 2007-01-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2007-01-11
• Last updated: 2015-01-26
• Results posted: 2014-06-02

Locations

159 sites across 29 countries: United States, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Croatia, Czechia, France, Germany, Greece, Guatemala, India, Israel, Italy, Mexico, Moldova, Netherlands, New Zealand, North Macedonia, Poland, Romania, Serbia, Slovakia, South Africa, Switzerland, Ukraine, United Kingdom, Virgin Islands