Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis
- Registration Number
- NCT00468611
- Lead Sponsor
- BioMS Technology Corp.
- Brief Summary
This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 510
Inclusion Criteria
- Male of female subjects, 18-65 years of age with a diagnosis of SPMS
- HLA DR2 and/or DR4 positive
- Absence of a relapse in the 3 months prior to baseline
- EDSS of 3.0 - 6.5
Exclusion Criteria
- Therapy with Beta-interferon, glatiramer acetate within 3 months or mitoxantrone, cyclophosphamide, methotrexate, azathioprine or any immune modulating or immunosuppressive drugs within 6 months of baseline
- Treatment with Tysabri within 2 years of baseline
- Females who are breast feeding, pregnant (pregnancy test at baseline) or not using a medically approved method of contraception regularly
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 MBP8298 - 2 MBP8298 -
- Primary Outcome Measures
Name Time Method Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment 24 Months
- Secondary Outcome Measures
Name Time Method To assess the safety of MBP8298, degree of change in the EDSS scores, effect of MBP8298 on MRI parameters, difference in relapse rates, effect on MSFC, subject's quality of life (MSQoL54) and fatigue (MFIS) after 24 months of treatment 24 Months