Safety of Riluzole in Patients With Acute Spinal Cord Injury

The Methodist Hospital Research Institute (TMHRI)

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Drug: Riluzole

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00876889

W81XWH-07-0042 (Other Identifier)

Pro00002029

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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