NCT00876889

Safety of Riluzole in Patients With Acute Spinal Cord Injury

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Riluzole	50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days (28 doses).

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-06-01
• Completion: 2012-04-01
• First posted: 2009-04-07
• Last updated: 2017-09-12

Locations

8 sites across 2 countries: United States, Canada