Status:
TERMINATED
Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis
Lead Sponsor:
BioMS Technology Corp.
Conditions:
Multiple Sclerosis, Secondary Progressive
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT00468611
Start Date
June 1 2007
End Date
September 1 2009
Last Update
August 13 2009
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