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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00666224 |
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 |
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Multiple Sclerosis |
Drug: Glatiramer Acetate Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With a Clinically Isolated Syndrome (CIS). |
Enrollment: | 482 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | June 2010 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Glatiramer acetate 20 mg once daily by subcutaneous route injection.
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Drug: Glatiramer Acetate
Injection, 20mg, once daily,for 36 months
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2: Placebo Comparator
Matching placebo once daily by subcutaneous route injection.
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Drug: Placebo
injection, once daily,for 36 months or until conversion to CDMS
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Teva Neuroscience ( Siyu Liu, Vice President, North American Innovative Research and Development and Head of Global Clinical Operations ) |
Study ID Numbers: | GA 9010 |
Study First Received: | April 22, 2008 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00666224 History of Changes |
Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
Clinically Definite Multiple Sclerosis Clinically Isolated Syndrome Multiple Sclerosis |
Copolymer 1 Autoimmune Diseases Multiple Sclerosis Immunologic Factors Demyelinating Diseases |
Adjuvants, Immunologic Demyelinating Autoimmune Diseases, CNS Sclerosis Immunosuppressive Agents Autoimmune Diseases of the Nervous System |
Autoimmune Diseases Disease Immunologic Factors Demyelinating Diseases Immune System Diseases Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Sclerosis |
Immunosuppressive Agents Pharmacologic Actions Copolymer 1 Multiple Sclerosis Pathologic Processes Syndrome Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |