Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis
Phase 4
Withdrawn
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Interventions
- Other: Placebo
- Registration Number
- NCT02472938
- Lead Sponsor
- Biogen
- Brief Summary
The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Participants with RRMS (McDonald criteria, 2010) who do not accept current injectable firstline DMTs.
- Multiple sclerosis (MS) onset within one year before enrolment
- ≥ 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment.
- No previous disease modifying and/or immunosuppressive treatments for MS.
- Must have a baseline EDSS between 0.0 and 5.0, inclusive. · Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Exclusion Criteria
- Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
- Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide
- Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates
- History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium.
- History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial.
- History of or positive test result at screening for human immunodeficiency virus (HIV).Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
- History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion.
- An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BG00012 dimethyl fumarate 120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter. Placebo Placebo Placebo capsules orally twice a day.
- Primary Outcome Measures
Name Time Method Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24) Week 24
- Secondary Outcome Measures
Name Time Method Mean number of CUA at 4, 8, 12, 16, 20 and 24 weeks Mean number of hypointense T1 lesions at 24 weeks New Gd+ lesions at 4, 8, 12, 16, 20 and 24 weeks New/enlarging T2 lesions at 4, 8, 12, 16, 20 and 24 weeks