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Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

Primary Purpose

Relapse Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
glatiramer acetate with minocycline
Glatiramer acetate with placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapse Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinically definite MS as defined by Poser et al. (Ann. Neurol. 1983) with disease duration (from onset) of at least 6 months. Subjects must have a relapsing-remitting disease course. Subjects must have had at least 1 documented relapse within the last year prior to study entry. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit. Subjects may be male or female. Women of child- bearing potential must use a contraceptive method deemed reliable by the investigator. Subjects must be between the ages of 18 and 50 years inclusive. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive. Subjects must be willing and able to give written informed consent prior to entering the study. Exclusion Criteria: Previous use of injectable glatiramer acetate. Previous use of cladribine. Previous use of immunosuppressive agents in the last 6 months. Use of experimental or investigational drugs, including I.V. immunoglobulin and statins, within 6 months prior to study entry. Use of interferon agents or minocycline within 4 months prior to the screening visit. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry. Previous total body irradiation or total lymphoid irradiation (TLI). Pregnancy or breast feeding. Subjects who experience a relapse between the screening (month -1) and baseline (month 0) visits. Significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse). A known history of sensitivity to mannitol. Contraindication to or known history of sensitivity to tetracyclines. A known history of sensitivity to gadolinium. Inability to successfully undergo MRI scanning.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Glatiramer Acetate injection with oral minocycline

    Glatiramer Acetate with placebo

    Arm Description

    Glatiramer Acetate 20mg with oral minocycline 100mg

    Glatiramer acetate injection 20mg with oral placebo

    Outcomes

    Primary Outcome Measures

    To evaluate the add-on treatment effect of oral minocycline in subjects treated with daily injection of GA as reflected by number of MRI T1 Gd-enhancing lesions in T1-weighted images.

    Secondary Outcome Measures

    Assessment of tolerability and safety

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    April 11, 2011
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00203112
    Brief Title
    Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline
    Official Title
    A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled, Parallel Study Assessing the Add-on Effect of Minocycline in Relapsing-Remitting Multiple Sclerosis (RR-MS) Subjects Treated With Glatiramer Acetate (GA).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study investigates the add-on effect of oral minocycline in subjects treated with daily injection of Copaxone. Copaxone and minocycline are thought to have differential modes of actions that may complement each other in treating MS symptoms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapse Remitting Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glatiramer Acetate injection with oral minocycline
    Arm Type
    Active Comparator
    Arm Description
    Glatiramer Acetate 20mg with oral minocycline 100mg
    Arm Title
    Glatiramer Acetate with placebo
    Arm Type
    Experimental
    Arm Description
    Glatiramer acetate injection 20mg with oral placebo
    Intervention Type
    Drug
    Intervention Name(s)
    glatiramer acetate with minocycline
    Other Intervention Name(s)
    Copaxone®
    Intervention Description
    Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg
    Intervention Type
    Drug
    Intervention Name(s)
    Glatiramer acetate with placebo
    Other Intervention Name(s)
    Copaxone®
    Intervention Description
    Subcutaneous injection glatiramer acetate 20mg, with oral placebo
    Primary Outcome Measure Information:
    Title
    To evaluate the add-on treatment effect of oral minocycline in subjects treated with daily injection of GA as reflected by number of MRI T1 Gd-enhancing lesions in T1-weighted images.
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Assessment of tolerability and safety
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinically definite MS as defined by Poser et al. (Ann. Neurol. 1983) with disease duration (from onset) of at least 6 months. Subjects must have a relapsing-remitting disease course. Subjects must have had at least 1 documented relapse within the last year prior to study entry. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit. Subjects may be male or female. Women of child- bearing potential must use a contraceptive method deemed reliable by the investigator. Subjects must be between the ages of 18 and 50 years inclusive. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive. Subjects must be willing and able to give written informed consent prior to entering the study. Exclusion Criteria: Previous use of injectable glatiramer acetate. Previous use of cladribine. Previous use of immunosuppressive agents in the last 6 months. Use of experimental or investigational drugs, including I.V. immunoglobulin and statins, within 6 months prior to study entry. Use of interferon agents or minocycline within 4 months prior to the screening visit. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry. Previous total body irradiation or total lymphoid irradiation (TLI). Pregnancy or breast feeding. Subjects who experience a relapse between the screening (month -1) and baseline (month 0) visits. Significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse). A known history of sensitivity to mannitol. Contraindication to or known history of sensitivity to tetracyclines. A known history of sensitivity to gadolinium. Inability to successfully undergo MRI scanning.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean Godin, MD
    Organizational Affiliation
    Teva Neuroscience Canada
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19776092
    Citation
    Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW; GA/minocycline study investigators. Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial. Mult Scler. 2009 Oct;15(10):1183-94. doi: 10.1177/1352458509106779. Epub 2009 Sep 23.
    Results Reference
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    Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

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