The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI).
The primary aim of the study is to develop acute care safety and pharmacokinetic profiles of riluzole in patients who have sustained a acute traumatic spinal cord injury. Secondary objectives are to conduct exploratory analyses of functional outcomes for purposes of planning a subsequent Phase II randomized study of the efficiency of Riluzole for the treatment of acute traumatic spinal cord injury.
Study Type
OBSERVATIONAL
Enrollment
36
50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days (28 doses).
University of Miami
Miami, Florida, United States
University of Louisville Health Sciences Center
Louisville, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
American Spinal Injury Association Impairment Scale
Neurological assessment and classification of spinal cord injury
Time frame: Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up
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The Methodist Hospital
Houston, Texas, United States
The University of Texas
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
University of Toronto/Toronto Western Hospital
Toronto, Ontario, Canada