MAESTRO-03: Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis

Sponsor

BioMS Technology Corp. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00468611

Collaborator

(none)

510

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Secondary Progressive	Drug: MBP8298	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

510 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jul 1, 2009

Anticipated Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: MBP8298 500mg MBP8298 IV every six months for a period of two years
Placebo Comparator: 2	Drug: MBP8298 500mg MBP8298 IV every six months for a period of two years

Arm

Intervention/Treatment

Experimental: 1

Drug: MBP8298

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

Placebo Comparator: 2

Drug: MBP8298

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.