Safety and Efficacy of BG00012 in Relapsing Remitting Multiple Sclerosis
- Conditions
- Multiple Sclerosis (Relapsing Remitting)Neurological - Multiple sclerosis
- Registration Number
- ACTRN12607000124437
- Lead Sponsor
- Biogen Idec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1011
Confirmed diagnosis of relapsing remitting multiple sclerosis according to McDonald criteria #1-4At least 1 relapse within 12 months prior to randomization with cranial MRI demonstrating MS consistent lesions, OR evidence of Gadolinium enhancing brain lesions on MRI within 6 weeks prior to randomisationBaseline Expanded Disability Status Score (EDSS) between 0.0 and 5.0.
Primary progressive, secondary progressive or progressive relapsing Multiple SclerosisAn MS relapse within 50 days of randomisation OR a patient who has not stabilised from a previous relapse prior to randomisationInability to perform Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) with both upper extremities, PASAT 3, or Visual Function testHistory of MalignancyHistory of severe allergic or anaphylactic reactions/known drug hypersensitivityHistory of HIVHistory of Drug or Alcohol abuse in last 2 yearsPositive for Hep C antibody and/or Hep B surface antigenAbnormal laboratory results indicative of major disease which would preclude clinical trial participationAny previous treatment with FUMADERM or BG00012/FAG-201History of other disallowed medication use outside of the time-frames specified in the protocolWomen of child-bearing potential not using adequate contraceptionEnrolment in other clinical trials within 6 months prior to randomisation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of relapsing subjects compared between BG00012 treatment groups and placebo group[At 2 years ]
- Secondary Outcome Measures
Name Time Method Annual relapse rate, rate of disability progression as measured by MSFC; (In a subset of patients: new or enlarging T2 hyperintense lesions, Gd-enhancing lesions and T1 hypointense lesions on brain MRI).[At 1 year]; Disability Progression as measured by EDSS and MSFC; (In a subset of patients: volume of T2 hyperintense and T1 hypointense lesions on brain MRI).[At 2 years]