Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glatiramer, N-Acetylcysteine · 2 trials · 1 indication
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...
Glatiramer is used for multiple sclerosis, specifically relapse-remitting multiple sclerosis, as well as optic neuritis and amyotrophic lateral sclerosis. It is being studied in clinical trials for these neurological conditions. The drug is developed by Teva Pharmaceutical Industries Limited.
Glatiramer targets the immune system in multiple sclerosis. It is a small molecule that modulates immune responses, though the exact molecular target is not specified. It is being investigated for its effects on relapse-remitting multiple sclerosis and other neurological conditions.
Glatiramer is developed by Teva Pharmaceutical Industries Limited, a company traded under the ticker TEVA. Teva is conducting clinical trials to evaluate the drug's effectiveness and safety for multiple sclerosis and related conditions.
Glatiramer is in Phase 3 clinical development. It has completed four trials, including Phase 3 studies for multiple sclerosis and optic neuritis. The drug is investigational and not yet approved, as it is still undergoing clinical evaluation.
Glatiramer has completed four clinical trials, including NCT00202982, NCT00666224, NCT00856635, and NCT01167426. These trials studied the drug in relapse-remitting multiple sclerosis, clinically isolated syndrome, optic neuritis, and multiple sclerosis, with a total enrollment of 2,746 participants.
Glatiramer is the active ingredient in Copaxone, a brand name for the drug. Clinical trials have tested higher doses of Copaxone, such as 40mg, compared to the approved 20mg dose. Glatiramer acetate is the full name of the compound.