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Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00203112
Collaborator
(none)
44
Enrollment
2
Arms
25
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: glatiramer acetate with minocycline
  • Drug: Glatiramer acetate with placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Jun 1, 2006
Actual Study Completion Date :
Jul 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Glatiramer Acetate injection with oral minocycline

Glatiramer Acetate 20mg with oral minocycline 100mg

Drug: glatiramer acetate with minocycline
Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg
Other Names:
  • Copaxone®

    		•
    Experimental: Glatiramer Acetate with placebo

    Glatiramer acetate injection 20mg with oral placebo

    Drug: Glatiramer acetate with placebo
    Subcutaneous injection glatiramer acetate 20mg, with oral placebo
    Other Names:
  • Copaxone®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [24 months]

    Secondary Outcome Measures

    1. Assessment of tolerability and safety [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Clinically definite MS as defined by Poser et al. (Ann. Neurol. 1983) with disease duration (from onset) of at least 6 months.

    2. Subjects must have a relapsing-remitting disease course.

    3. Subjects must have had at least 1 documented relapse within the last year prior to study entry.

    4. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan.

    5. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.

    6. Subjects may be male or female. Women of child- bearing potential must use a contraceptive method deemed reliable by the investigator.

    7. Subjects must be between the ages of 18 and 50 years inclusive.

    8. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive.

    9. Subjects must be willing and able to give written informed consent prior to entering the study.

    Exclusion Criteria:

    1. Previous use of injectable glatiramer acetate.

    2. Previous use of cladribine.

    3. Previous use of immunosuppressive agents in the last 6 months.

    4. Use of experimental or investigational drugs, including I.V. immunoglobulin and statins, within 6 months prior to study entry.

    5. Use of interferon agents or minocycline within 4 months prior to the screening visit.

    6. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.

    7. Previous total body irradiation or total lymphoid irradiation (TLI).

    8. Pregnancy or breast feeding.

    9. Subjects who experience a relapse between the screening (month -1) and baseline (month

    1. visits.

    1. 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).

    2. A known history of sensitivity to mannitol.

    3. Contraindication to or known history of sensitivity to tetracyclines.

    4. A known history of sensitivity to gadolinium.

    5. Inability to successfully undergo MRI scanning.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Teva Branded Pharmaceutical Products R&D, Inc.

    Investigators

    • Study Director: Jean Godin, MD, Teva Neuroscience Canada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00203112
    Other Study ID Numbers:
    • GA 9014
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Apr 12, 2011
    Last Verified:
    Apr 1, 2011
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Minocycline
    Glatiramer Acetate
    (T,G)-A-L

    Study Results

    No Results Posted as of Apr 12, 2011