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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00203099
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

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.

Condition or disease Intervention/treatment Phase
Relapse Remitting Multiple Sclerosis Drug: Glatiramer Acetate, N-Acetylcysteine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Glatiramer Acetate, N-Acetylcysteine Drug: Glatiramer Acetate, N-Acetylcysteine
Subcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses.

Primary Outcome Measures :
  1. Change in the sum of T1 Gd-enhancing lesions as reflected by MRI [ Time Frame: 46 weeks ]
    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 :
  1. MRI parameters [ Time Frame: 46 Weeks ]
    Evaluation of secondary efficacy MRI parameters and assessments of tolerability and safety.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00203099

Sponsors and Collaborators
Teva Pharmaceutical Industries
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Study Director: Jean Godin, MD Teva Neuroscience Canada

Additional Information:
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Responsible Party: Teva Pharmaceutical Industries Identifier: NCT00203099     History of Changes
Other Study ID Numbers: GA 9015
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Glatiramer Acetate
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Antirheumatic Agents