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Safety of Riluzole in Patients With Acute Spinal Cord Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Christopher Reeve Paralysis Foundation
Department of Defense
AO Clinical Investigation and Documentation
Ontario Neurotrauma Foundation
Information provided by:
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00876889
First received: March 25, 2009
Last updated: June 28, 2011
Last verified: June 2011
History of Changes

March 25, 2009
June 28, 2011
April 2010
June 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00876889 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Safety of Riluzole in Patients With Acute Spinal Cord Injury
Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury

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).

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.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma and cerebral spinal fluid
Non-Probability Sample

Admitted to a NACTN hospital
Spinal Cord Injury
Drug: Riluzole
50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days (28 doses).
Other Name: Rilutek
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
April 2012
June 2011   (final data collection date for primary outcome measure)

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 NG 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00876889
00002029, W81XWH-07-1-0361
No
Robert G. Grossman, MD, The Methodist Hospital System
The Methodist Hospital System
  • Christopher Reeve Paralysis Foundation
  • Department of Defense
  • AO Clinical Investigation and Documentation
  • Ontario Neurotrauma Foundation
Study Chair: Robert G Grossman, MD The Methodist Hospital, Houston
Principal Investigator: Michael Fehlings, MD, PhD University of Toronto/Toronto Western Hospital, Toronto
Principal Investigator: Michele M Johnson, MD the University of Houston/Memorial HermannHospital, Houston
Principal Investigator: Christopher Shaffery, MD University of Virginia Health System, Charlottesville
Principal Investigator: Susan Harkema, PhD University of Louisville, Louisville
Principal Investigator: Bizhan Aarabi, MD University of Maryland Medical Center, Baltimore
Principal Investigator: James Harrop, MD Thomas Jefferson University, Philadelphia
Principal Investigator: James Guest, MD, PhD University of Miami, Miami
Principal Investigator: Ralph Frankowski, PhD The University of Texas School of Public Health, Houston
Principal Investigator: Diana Chow, PhD University of Houston, College of Pharmacy, Houston
The Methodist Hospital System
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP