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

This study has been terminated.
(Negative efficacy results of the MAESTRO-01 study)
Sponsor:
Information provided by:
BioMS Technology Corp.
ClinicalTrials.gov Identifier:
NCT00468611
First received: May 1, 2007
Last updated: August 12, 2009
Last verified: August 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis, Secondary Progressive
 Drug: MBP8298
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BioMS Technology Corp.:

Primary Outcome Measures:
  • Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

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 [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

Enrollment: 510
Study Start Date: June 2007
Estimated Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468611

Sponsors and Collaborators
BioMS Technology Corp.
Investigators
Principal Investigator: Clyde E Markowitz, MD University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00468611     History of Changes
Other Study ID Numbers: MBP8298-SP-03
Study First Received: May 1, 2007
Last Updated: August 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by BioMS Technology Corp.:
Secondary Progressive Multiple Sclerosis
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013