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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis

Intervention: Glatiramer Acetate (GA) 40 mg (Drug); glatiramer acetate 20 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Teva Pharmaceutical Industries

Official(s) and/or principal investigator(s):
Chen Duksin, MD, Study Chair, Affiliation: Teva Pharmaceutical Industries, Ltd.
Giancarlo Comi, Prof, Principal Investigator, Affiliation: Istituto Scientifico Fondazione Centro S. Raffaele

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 CopaxoneŽ (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.

Clinical Details

Official title: A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to That of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting (R-R) Multiple Sclerosis (MS)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).

Secondary outcome:

The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.

The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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 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. 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 Criteria: 1. Previous use of Copaxone (glatiramer acetate) 2. Treatment with corticosteroids within 30 days prior screening or between screening and baseline.

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 screening and thereafter). 6. Known history of sensitivity to Gadolinium and inability to successfully undergo MRI scanning.

Locations and Contacts

Additional Information

Starting date: August 2006
Last updated: October 6, 2011

Page last updated: August 20, 2015

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