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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
BioMS Technology Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    May 1, 2007
    Last Updated
    August 12, 2009
    Sponsor
    BioMS Technology Corp.
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    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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