Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00203099 | Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine | PHASE2 | COMPLETED | 18 | — | — | Dec 1, 2004 | Jun 1, 2008 | May 14, 2012 | - | — |
| NCT00203112 | Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline | PHASE2 | COMPLETED | 44 | — | — | Jun 1, 2004 | Jul 1, 2006 | Apr 12, 2011 | - | — |
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 \[termination\]).
| Arm | Type | Description |
|---|---|---|
| Glatiramer Acetate, N-Acetylcysteine | ACTIVE_COMPARATOR | - |
| Glatiramer Acetate injection with oral minocycline | ACTIVE_COMPARATOR | Glatiramer Acetate 20mg with oral minocycline 100mg |
| Glatiramer Acetate with placebo | EXPERIMENTAL | Glatiramer acetate injection 20mg with oral placebo |
| Name | Type | Description |
|---|---|---|
| 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 with minocycline | DRUG | Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg |
| Glatiramer acetate with placebo | DRUG | Subcutaneous injection glatiramer acetate 20mg, with oral placebo |
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...