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

BioMS Technology

Status and phase: Terminated; Phase 3

Conditions: Multiple Sclerosis, Secondary Progressive

Treatments: Drug: MBP8298

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468611

MBP8298-SP-03

Details and patient eligibility

About

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

Enrollment: 510 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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510 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: MBP8298

2

Placebo Comparator group

Treatment:

Drug: MBP8298