This trial is active, not recruiting.

Condition multiple sclerosis, relapsing-remitting
Treatment dimethyl fumarate
Phase phase 3
Sponsor Biogen
Start date February 2016
End date August 2018
Trial size 20 participants
Trial identifier NCT02555215, 109MS311, 2015-003282-29


The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Participants will receive 120 mg capsule(s) taken orally.
dimethyl fumarate DMF
administered orally

Primary Outcomes

The number of participants that experience adverse events (AEs) and serious adverse events (SAEs).
time frame: Week 96
The number of participants that discontinue study treatment due to an AE.
time frame: Week 96

Secondary Outcomes

The total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans.
time frame: Week 72
The annualized relapse rate
time frame: Week 96
The proportion of subjects who experience 1 or more relapses during the study period.
time frame: Week 96
The degree of disability progression from baseline as measured by the Expanded Disability Status Scale (EDSS).
time frame: Up to week 24

Eligibility Criteria

Male or female participants from 10 years up to 17 years old.

Key Inclusion Criteria: - Ability of parents, legal guardians, and/or subjects to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parental or guardian consent, as appropriate, per local regulations. - Subjects who completed, as per protocol, the previous BG00012 clinical study 109MS202 (NCT02410200) and remain on BG00012 treatment. Key Exclusion Criteria: - Unwillingness or inability to comply with study requirements, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol. - Any significant changes in medical history occurring after enrollment in the parent Study 109MS202 (NCT02410200), including laboratory test abnormalities or current clinically significant conditions that in the opinion of the Investigator would have excluded the subject's participation from the parent study. The Investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment. - Subjects from Study 109MS202 (NCT02410200) who could not tolerate study treatment. NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Additional Information

Official title A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Biogen.