Safety of Riluzole in Patients With Acute Spinal Cord Injury

Completed

Conditions studied: Spinal Cord Injury

In brief

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).

Key facts

Study ID

NCT00876889

Run by

The Methodist Hospital Research Institute

People needed

36

Starts

2010-04-01

Expected to finish

2012-04-01

Last updated by the study team

2017-09-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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