CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,417 enrolled
Drug / intervention
BG00012 +2 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/NCT00451451
NCT00451451Phase 3Completed

A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

Biogen·interventional·Posted Mar 23, 2007·Updated Jan 26, 2015

In Brief

A Phase 3 clinical trial evaluating BG00012, Placebo, and 1 other intervention for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 1,417 participants across 195 sites in 28 countries.

Detailed Summary

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are 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 MS to get worse. Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Costa Rica, Croatia, Czechia, Estonia, France, Germany, Greece, India, Ireland, Israel, Latvia, Mexico, Moldova, New Zealand, North Macedonia, Poland, Puerto Rico, Romania, Serbia, Slovakia, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 23, 2007
Enrollment StartJun 1, 2007
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 19.3 years ago

Interventions

BG00012drug

Placebodrug

Glatiramer Acetatedrug