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

Phase 3TerminatedNCT00468611

BioMS Technology Corp.510 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

510

Conditions

Multiple Sclerosis, Secondary Progressive

Interventions

MBP8298DRUG

500mg MBP8298 IV every six months for a period of two years

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment

Time frame: 24 Months

Secondary Outcomes

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

Time frame: 24 Months

Data from ClinicalTrials.gov

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