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

Phase 3

Completed

• Conditions: multiple sclerosis; 10007951

• Registration Number: NL-OMON31459
• Lead Sponsor: Biogen Idec Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

-written informed consent
-aged 18 to 55 years old
-confirmed diagnosis of relapsing-remitting multiple sclerosis
-baseline EDDS between 0.0 and 5.0 inclusive (expanded disability status scale)
-must have experienced at least 1 relapse within the 12 months prior to randomization

Exclusion Criteria

-primary progressive, secondary progressive, or progressive elapsing MS
-unable to perform the Timed 25-Foot Walk, Nine-Hole Peg Test (9HTP) with both upper extremities, and PASAT 3
-unable to perform visual function tests
-history of malignancy
-history of severe allergic of anaphylactic reactions or known drug hypersensitivity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary analysis will be a Cox proportional hazards model for time to first<br /><br>relapse. The proportion of subjects relapsed at 2 years will be estimated from<br /><br>the Kaplan-Meier survival curve distribution. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Annualized relapse rate at 1 year will be analyzed using Poisson regression.<br /><br><br /><br>Disability progression as measured by EDSS will be<br /><br>analyzed using a Cox proportional hazards model.<br /><br><br /><br>The number of new or newly enlarging T2 hyperintense lesions and Gd-enhancing<br /><br>lesions will be analyzed using multiple logit regression. </p><br>