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

Multiple Sclerosis, Secondary Progressive Clinical Trial

— MAESTRO-03  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00468611
• Other study ID #: MBP8298-SP-03
• Status: Terminated
• Phase: Phase 3
• First received: May 1, 2007
• Last updated: August 12, 2009
• Start date: June 2007
• Est. completion date: September 2009

Study information

• Verified date: August 2009
• Source: BioMS Technology Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 510
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Secondary Progressive
• Neoplasm Metastasis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioMS Technology Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment		24 Months	No
Secondary	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	Yes