Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine
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|ClinicalTrials.gov Identifier: NCT00203099|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Relapse Remitting Multiple Sclerosis||Drug: Glatiramer Acetate, N-Acetylcysteine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||December 2004|
|Primary Completion Date :||August 2006|
|Study Completion Date :||June 2008|
|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.
- 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]).
- MRI parameters [ Time Frame: 46 Weeks ]Evaluation of secondary efficacy MRI parameters and assessments of tolerability and safety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203099
|Study Director:||Jean Godin, MD||Teva Neuroscience Canada|