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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.
ClinicalTrials.gov Identifier: NCT00203099
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 14, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date May 14, 2012
Study Start Date  ICMJE December 2004
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2011)
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]).
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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]).
Change History Complete list of historical versions of study NCT00203099 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2011)
MRI parameters [ Time Frame: 46 Weeks ]
Evaluation of secondary efficacy MRI parameters and assessments of tolerability and safety.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapse Remitting Multiple Sclerosis
Intervention  ICMJE Drug: Glatiramer Acetate, N-Acetylcysteine
Subcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses.
Study Arms  ICMJE Active Comparator: Glatiramer Acetate, N-Acetylcysteine
Intervention: Drug: Glatiramer Acetate, N-Acetylcysteine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
18
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00203099
Other Study ID Numbers  ICMJE GA 9015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries
Study Sponsor  ICMJE Teva Pharmaceutical Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jean Godin, MD Teva Neuroscience Canada
PRS Account Teva Pharmaceutical Industries
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP