CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,234 enrolled
Drug / intervention
BG00012 +1 moredrug
Likely dose
Not stated in 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.

Search/NCT00420212
NCT00420212Phase 3Completed

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

Biogen·interventional·Posted Jan 11, 2007·Updated Jan 26, 2015

In Brief

A Phase 3 clinical trial evaluating BG00012 and Placebo for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 1,234 participants across 159 sites in 29 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, 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, United States, Virgin Islands
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2007
Enrollment StartJan 1, 2007
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 19.5 years ago

Interventions

BG00012drug

Placebodrug