Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMS Technology Corp.

Criteria

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.