Overview

This trial is active, not recruiting.

Condition relapsing-remitting multiple sclerosis
Treatments dimethyl fumarate, placebo
Phase phase 3
Sponsor Biogen
Start date February 2009
End date February 2023
Trial size 1738 participants
Trial identifier NCT00835770, 109MS303, 2008-004753-14

Summary

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
In the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for up to 12 years.
dimethyl fumarate BG00012
BG00012 capsules
placebo
Capsules taken to maintain the blind in the 240 mg BID treatment group.
(Experimental)
In the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for up to 12 years.
dimethyl fumarate BG00012
BG00012 capsules

Primary Outcomes

Measure
Number of Participants with Adverse Events
time frame: Day 1 up to 12 years

Secondary Outcomes

Measure
Number of Participants Who Had Relapses
time frame: Day 1 up to 12 years
Annualized Relapse Rate (ARR)
time frame: Day 1 up to 12 years
Change from Baseline in the Expanded Disability Status Scale (EDSS) up to 12 years
time frame: Day 1 up to 12 years
Number and volume of Gd-enhancing lesions as Measured by Magnetic Resonance Imaging (MRI)
time frame: Day 1 up to 12 years
Number and volume of new or newly-enlarging T2 lesions as Measured by Magnetic Resonance Imaging (MRI)
time frame: Day 1 up to 12 years
Number and volume of T1 hypointense lesions
time frame: Day 1 to 12 years
Change from Baseline in Brain atrophy up to 12 years
time frame: Day 1 to 12 years
Summary of Magnetization Transfer Ratio (MTR)
time frame: Day 1 to 12 years
Change from Baseline in EQ-5D Health Survey (EQ-5D) up to 12 years
time frame: Day 1 to 12 years
Change from baseline in SF-36® Health Survey (SF-36) up to 12 years
time frame: Day 1 to 12 years
Change from Baseline in Visual Function test scores up to 12 years
time frame: Day 1 to 12 years

Eligibility Criteria

Male or female participants from 19 years up to 58 years old.

Key Inclusion Criteria: -Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451). Key Exclusion Criteria: - Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study. - Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression. - Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Information

Official title A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis
Description The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the initiation of this study, BG00012 was approved in several countries for the treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this study will receive the currently marketed dose of 240 mg BID.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Biogen.