Status:
COMPLETED
Safety of Riluzole in Patients With Acute Spinal Cord Injury
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Christopher Reeve Paralysis Foundation
United States Department of Defense
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-70 years
Brief Summary
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
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00876889
Start Date
April 1 2010
End Date
April 1 2012
Last Update
September 12 2017
Active Locations (8)
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1
University of Miami
Miami, Florida, United States, 33136
2
University of Louisville Health Sciences Center
Louisville, Kentucky, United States, 40205
3
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
4
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107