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Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine

Primary Purpose

Relapse Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Glatiramer Acetate, N-Acetylcysteine
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 Multiple Sclerosis (CDMS) as defined by Poser et al (Ann Neurol 1983). Subjects must have at least one T1 Gd-enhancing lesion in one of the pre-treatment MRI scans. Subjects must have a relapsing-remitting disease course. Subjects must have had at least one documented relapse within the last year prior to the screening visit (week -10). 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 practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive or double-barrier method (condom or IUD with spermicide). 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 injected glatiramer acetate. Previous use of cladribine within 2 years prior to screening visit (week -10). Previous use of immunosuppressive agents in the last 6 months. Use of experimental or investigational drugs, including I.V. immunoglobulin, within 6 months prior to study entry. Use of interferon agents within 60 days 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. Chronic use of antioxidant substance(s), including NAC, (more than 30 consecutive days) within 60 days prior to the screening visit. Previous total body irradiation or total lymphoid irradiation (TLI). Pregnancy or breastfeeding. 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 uncontrolled asthma. A known history of sensitivity to mannitol or acetylcysteine. Inability to successfully undergo MRI scanning.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    Glatiramer Acetate, N-Acetylcysteine

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in the sum of T1 Gd-enhancing lesions as reflected by MRI
    Change in the sum of T1 Gd-enhancing lesions measured at pre-treatment (weeks -10 [screening], -6 and 0 [baseline]) to the sum of T1 Gd-enhancing lesions measured in the last study trimester (weeks 28, 32 and 36 [termination]).

    Secondary Outcome Measures

    MRI parameters
    Evaluation of secondary efficacy MRI parameters and assessments of tolerability and safety.

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    May 11, 2012
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00203099
    Brief Title
    Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine
    Official Title
    A Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This study evaluates the effect of the therapy combining GA and NAC on disease activity as reflected by MRI parameters while assessing tolerability and safety.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glatiramer Acetate, N-Acetylcysteine
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Glatiramer Acetate, N-Acetylcysteine
    Intervention Description
    Subcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses.
    Primary Outcome Measure Information:
    Title
    Change in the sum of T1 Gd-enhancing lesions as reflected by MRI
    Description
    Change in the sum of T1 Gd-enhancing lesions measured at pre-treatment (weeks -10 [screening], -6 and 0 [baseline]) to the sum of T1 Gd-enhancing lesions measured in the last study trimester (weeks 28, 32 and 36 [termination]).
    Time Frame
    46 weeks
    Secondary Outcome Measure Information:
    Title
    MRI parameters
    Description
    Evaluation of secondary efficacy MRI parameters and assessments of tolerability and safety.
    Time Frame
    46 Weeks

    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 Multiple Sclerosis (CDMS) as defined by Poser et al (Ann Neurol 1983). Subjects must have at least one T1 Gd-enhancing lesion in one of the pre-treatment MRI scans. Subjects must have a relapsing-remitting disease course. Subjects must have had at least one documented relapse within the last year prior to the screening visit (week -10). 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 practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive or double-barrier method (condom or IUD with spermicide). 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 injected glatiramer acetate. Previous use of cladribine within 2 years prior to screening visit (week -10). Previous use of immunosuppressive agents in the last 6 months. Use of experimental or investigational drugs, including I.V. immunoglobulin, within 6 months prior to study entry. Use of interferon agents within 60 days 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. Chronic use of antioxidant substance(s), including NAC, (more than 30 consecutive days) within 60 days prior to the screening visit. Previous total body irradiation or total lymphoid irradiation (TLI). Pregnancy or breastfeeding. 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 uncontrolled asthma. A known history of sensitivity to mannitol or acetylcysteine. 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

    Learn more about this trial

    Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine

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