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

NCT00337779 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1155

Last updated 2011-10-10

Study results available
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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.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

Glatiramer Acetate (GA) 40 mg

Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months

DRUG

glatiramer acetate 20 mg

Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Chen Duksin, MD · Teva Pharmaceutical Industries, Ltd.

  • Giancarlo Comi, Prof · Istituto Scientifico Fondazione Centro S. Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00337779 on ClinicalTrials.gov