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

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)

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.

Study Overview

• Status: Completed
• Conditions: Relapse Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Glatiramer Acetate, N-Acetylcysteine

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI parameters	Evaluation of secondary efficacy MRI parameters and assessments of tolerability and safety.	46 Weeks

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Jean Godin, MD, Teva Neuroscience Canada

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): May 14, 2012
• Last Update Submitted That Met QC Criteria: May 11, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine; Glatiramer Acetate; (T,G)-A-L
• Other Study ID Numbers: GA 9015