Phase 3
Completed N=1,155
Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
Source: ClinicalTrials.gov NCT00337779 ↗Enrolled (actual)
1,155
Serious AEs
4.2%
Results posted
May 2010
Primary outcomePrimary: The Rate of Confirmed Relapses During the Double-blind Phase (12 Months). — 0.28; 0.27 Number of relapses per patient — p=0.4859
Summary
Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties. The study treatment duration is 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Rate of Confirmed Relapses During the Double-blind Phase (12 Months). |
0.28; 0.27 | 0.4859 |
| SECONDARY The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan. |
2.87; 2.72 | — |
| SECONDARY The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below). |
2.83; 3.49 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of confirmed and documented MS defined by the Revised McDonald criteria.
- Subjects must be of the relapsing-remitting (R-R) type.
- Subject has experienced prior to screening at least one documented relapse in 12 months or at least 2 documented relapses in the 24 months or one documented relapse between 12 - 24 months with at least 1 documented T1-Gd enhancing lesion in the MRI performed 12 months prior screening.
- Disease duration for at least 6 months.
- Ambulatory with converted Kurtzke EDSS score of 0 - 5.
- Relapse free and stable neurological condition at least for 30 days prior screening.
- Age - 18-55 (inclusive)
Exclusion Criteria
- Previous use of Copaxone (glatiramer acetate)
- Treatment with corticosteroids within 30 days prior screening or between screening and baseline.
- Chronic corticosteroids treatment - more than 30 consecutive days.
- Subject with any clinically significant or unstable medical condition.
- Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
- Known history of sensitivity to Gadolinium and inability to successfully undergo MRI scanning.
Data sourced from ClinicalTrials.gov (NCT00337779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.