Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis (MAESTRO-03)
Primary Purpose
Multiple Sclerosis, Secondary Progressive
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MBP8298
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Secondary Progressive focused on measuring Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00468611
Brief Title
Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
Negative efficacy results of the MAESTRO-01 study
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
BioMS Technology Corp.
4. Oversight
Data Monitoring Committee
Yes
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Secondary Progressive
Keywords
Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
510 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MBP8298
Intervention Description
500mg MBP8298 IV every six months for a period of two years
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clyde E Markowitz, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis
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