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

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00203099

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

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 :

Dec 1, 2004

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in the sum of T1 Gd-enhancing lesions as reflected by MRI [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

MRI parameters [46 Weeks]
Evaluation of secondary efficacy MRI parameters and assessments of tolerability and safety.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.