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
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