Safety of Riluzole in Patients With Acute Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876889
• Other study ID #: Pro00002029
• Secondary ID: W81XWH-07-0042
• Status: Completed
• Phase: N/A
• First received: March 25, 2009
• Last updated: September 11, 2017
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: September 2017
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Canada	University of Toronto/Toronto Western Hospital	Toronto	Ontario
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Virginia Health System	Charlottesville	Virginia
United States	The Methodist Hospital	Houston	Texas
United States	The University of Texas	Houston	Texas
United States	University of Louisville Health Sciences Center	Louisville	Kentucky
United States	University of Miami	Miami	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
The Methodist Hospital System	AO Clinical Investigation and Documentation, Christopher Reeve Paralysis Foundation, Ontario Neurotrauma Foundation, United States Department of Defense

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   The Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research, and improving the quality of life for people living with paralysis through grants, information and advocacy. Click here for more information about the network.