Status:
COMPLETED
Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief 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 medi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
1155 Patients enrolled
Trial Details
Trial ID
NCT00337779
Start Date
August 1 2006
End Date
October 1 2008
Last Update
October 10 2011
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