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

NCT00203099 | Completed Phase 2

• 1 other identifier: GA 9015
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relapse Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 \[termination\]).

  46 weeks

Secondary Outcomes (1)

• MRI parameters

  46 Weeks

Study Arms (1)

Glatiramer Acetate, N-Acetylcysteine

ACTIVE COMPARATOR

Drug: Glatiramer Acetate, N-Acetylcysteine

Interventions

Glatiramer Acetate, N-Acetylcysteine DRUG

Subcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses.

Glatiramer Acetate, N-Acetylcysteine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Interventions

Glatiramer Acetate; Acetylcysteine

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids

Study Officials

• Jean Godin, MD

  Teva Neuroscience Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: December 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: June 1, 2008
• Last Updated: May 14, 2012

Record last verified: 2012-05