Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).

Last updated: October 6, 2011
Sponsor: Teva Pharmaceutical Industries
Overall Status: Completed

Phase

3

Condition

Memory Loss

Neurologic Disorders

Multiple Sclerosis

Treatment

N/A

Clinical Study ID

NCT00337779
GA/9016 (FORTE)
  • Ages 18-55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of confirmed and documented MS defined by the Revised McDonald criteria.

  2. Subjects must be of the relapsing-remitting (R-R) type.

  3. Subject has experienced prior to screening at least one documented relapse in 12months or at least 2 documented relapses in the 24 months or one documented relapsebetween 12 - 24 months with at least 1 documented T1-Gd enhancing lesion in the MRIperformed 12 months prior screening.

  4. Disease duration for at least 6 months.

  5. Ambulatory with converted Kurtzke EDSS score of 0 - 5.

  6. Relapse free and stable neurological condition at least for 30 days prior screening.

  7. Age - 18-55 (inclusive)

Exclusion

Exclusion Criteria:

  1. Previous use of Copaxone (glatiramer acetate)

  2. Treatment with corticosteroids within 30 days prior screening or between screening andbaseline.

  3. Chronic corticosteroids treatment - more than 30 consecutive days.

  4. Subject with any clinically significant or unstable medical condition.

  5. Subjects participating in any other clinical trial (within 12 weeks prior to screeningand thereafter).

  6. Known history of sensitivity to Gadolinium and inability to successfully undergo MRIscanning.

Study Design

Total Participants: 1155
Study Start date:
August 01, 2006
Estimated Completion Date:
October 31, 2008