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| Sponsor: | Teva Pharmaceutical Industries |
|---|---|
| Information provided by: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT00666224 |
Purpose
The primary objective is to assess the effect of treatment with glatiramer acetate (GA) compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the occurrence of the second clinical attack) during the double-blind phase. The secondary objective is to assess, within the time frame of the up to 3-year placebo-controlled study period, the effect of GA on clinical and MRI parameters. The long-term objective of the study is to assess, within the time frame of 5 years, the neuroprotective effect of early versus delayed treatment with GA as reflected by clinical and MRI parameters measuring the accumulated irreversible brain tissue damage.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Glatiramer Acetate Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to CDMS of Subjects Presenting With CIS |
| Enrollment: | 482 |
| Study Start Date: | January 2004 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Glatiramer acetate 20 mg once daily by subcutaneous route injection.
|
Drug: Glatiramer Acetate
Injection, 20mg, once daily,for 36 months
|
|
Placebo Comparator: 2
Matching placebo once daily by subcutaneous route injection.
|
Drug: Placebo
injection, once daily,for 36 months or until conversion to CDMS
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 97 Study Locations
More Information
| Responsible Party: | Siyu Liu, Vice President, North American IR&D and Head of Global Clinical Operations, Teva Branded Pharmaceutical Products R&D, Inc. |
| ClinicalTrials.gov Identifier: | NCT00666224 History of Changes |
| Other Study ID Numbers: | GA 9010 |
| Study First Received: | April 22, 2008 |
| Last Updated: | April 4, 2011 |
| Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
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Clinically Definite Multiple Sclerosis Clinically Isolated Syndrome Multiple Sclerosis |
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Copolymer 1 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents |