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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00093275 |
The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI).
Condition | Intervention | Phase |
---|---|---|
Spinal Cord Injury |
Drug: HP184 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of HP184 Administered Orally Once Daily for Twenty-Four Weeks in Adult Subjects With Chronic Spinal Cord Injury (CSCI) |
Enrollment: | 262 |
Study Start Date: | October 2004 |
Study Completion Date: | December 2005 |
Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Sanofi-aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Australia | |
sanofi-aventis administrative Australia & New-Zealand administrative office | |
Macquarie Park, New South Wales, Australia | |
Germany | |
Sanofi-aventis Administrative Office | |
Berlin, Germany | |
India | |
Sanofi-aventis Administrative Office | |
Mumbai, India | |
United Kingdom | |
Sanofi-aventis Administrative Office | |
Guildford Surrey, United Kingdom |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | DRI6213, HP184B/2002 |
Study First Received: | October 5, 2004 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00093275 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Spinal Cord Injuries Spinal Cord Diseases Nervous System Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |