Safety of Riluzole in Patients With Acute Spinal Cord Injury

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Drug: Riluzole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age equal to or greater than 18 years and less than or equal to 70 years; Willing to give written informed consent to participate in the study. The informed consent may require legally authorized representative to sign if arm/hand function is compromised. No other life-threatening injury Spinal cord injury at the neurologic level from C4 to T12 ASIA Impairment Scale level A, B or C No cognitive impairment which would preclude an informed consent (including moderate or severe traumatic brain injury) Less than 12 hours since injury Exclusion Criteria: Equal or more than 12 hours since injury Hypersensitivity to riluzole or any of its components Unable to receive riluzole orally or via nasogastric tube History of liver or kidney disease (e.g. Hepatitis A, B or C, Cirrhosis, etc.) Has a recent history of regular substance abuse (illicit drugs, alcohol) Unconscious Penetrating spinal cord injury Pregnancy as established by urine pregnancy test Breastfeeding Life expectancy less than 12 months Is currently involved in another therapeutic SCI research study that precludes or complicates participation in this study (e.g. study of another therapeutic drug aiming for spinal cord injury recovery, any study that substantially interferes with the follow -up schedule (f/u) schedule, or any high risk study that complicates evaluation of safety outcomes. Types of studies that would not preclude participation are e.g. behavioral adaptation studies, mental health interventions) Has a mental disorder or other illness, which in the view of the site investigator, would preclude accurate evaluation (e.g. schizophrenia, severe cognitive disability, Parkinson disease) Unable to commit to the follow-up schedule Is a prisoner Unable to converse, read or write English at the elementary school level

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Riluzole|50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days (28 doses).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Spinal Injury Association Impairment Scale | Neurological assessment and classification of spinal cord injury | Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, riluzole, pharmacokinetics, Acute Traumatic Spinal Cord Injury