109MS308 - BG00012 in subjects with SPMS
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis.
IRAS ID
172600
Contact name
Jason Morrow
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2014-003021-18
Duration of Study in the UK
3 years, 8 months, 0 days
Research summary
This is a Phase 3, multicentre, international, randomised, double-blind, placebo-controlled study to assess the efficacy and safety of BG00012 in delaying disability progression in subjects with Secondary Progressive Multiple Sclerosis (SPMS).
Approximately 1170 subjects will be enrolled and randomised into this study at approximately 200 sites.
The main purpose of this study is to find out if BG00012 (Tecfidera®) is effective in slowing the progression of disability in patients with SPMS. Subjects will be randomised, to one of the following treatment groups: BG00012 Treatment Group and Placebo Group. All subjects will take 2 capsules orally twice a day (a total of 4 capsules a day) during the Treatment Period. Subjects in the BG00012 Treatment Group will receive BG00012 120 mg twice a day for 1 week, and an increased dose of BG00012 240 mg twice a day beginning on Day 8 for up to 108 weeks. Subjects in the Placebo Group will receive BG00012 120 mg once daily randomly in the morning or evening for the first 4 weeks of treatment, and matched placebo thereafter.
The study period will consist of a Screening Period of up to 4 weeks, a 108-week blinded Treatment Period, and follow-up at approximately 4 weeks after the last dose of study treatment. Following completion of this study, the patients will have the
option to enroll into an extension study where all patients will receive BG00012 capsules.BG00012 (Tecfidera®) is an investigational product approved for the treatment of patients with relapsing Multiple Sclerosis or relapsing remitting Multiple Sclerosis in the Unites States, Canada, Australia and the European Union. It is not approved for treatment of patients with SPMS and this study will help to gather information about whether BG00012 is effective in slowing the progression of disability in patients with SPMS.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/0896
Date of REC Opinion
7 Jul 2015
REC opinion
Further Information Favourable Opinion