Multiple Sclerosis, Secondary Progressive
Conditions
Keywords
Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
Brief summary
This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)
Interventions
DRUGMBP8298
500mg MBP8298 IV every six months for a period of two years
Sponsors
BioMS Technology Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment | 24 Months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed