Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glatiramer Acetate, N-Acetylcysteine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glatiramer Acetate, N-Acetylcysteine | Drug | Subcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MRI parameters | Evaluation of secondary efficacy MRI parameters and assessments of tolerability and safety. | 46 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean Godin, MD | Teva Neuroscience Canada | Study Director |
Not provided
| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |