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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:
ClinicalTrials.gov Identifier:
NCT00468611
First Posted: May 3, 2007
Last Update Posted: August 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
BioMS Technology Corp.
  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
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

Resource links provided by NLM:


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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468611


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

ClinicalTrials.gov Identifier: NCT00468611     History of Changes
Other Study ID Numbers: MBP8298-SP-03
First Submitted: May 1, 2007
First Posted: May 3, 2007
Last Update Posted: August 13, 2009
Last Verified: August 2009

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

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