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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203099
First received: September 13, 2005
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Relapse Remitting Multiple Sclerosis
Drug: Glatiramer Acetate, N-Acetylcysteine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change in the sum of T1 Gd-enhancing lesions as reflected by MRI [ Time Frame: 46 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 46 Weeks ] [ Designated as safety issue: Yes ]
    Evaluation of secondary efficacy MRI parameters and assessments of tolerability and safety.


Enrollment: 18
Study Start Date: December 2004
Study Completion Date: June 2008
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203099

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

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00203099     History of Changes
Other Study ID Numbers: GA 9015
Study First Received: September 13, 2005
Last Updated: May 11, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Acetylcysteine
N-monoacetylcystine
Copolymer 1
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 20, 2014