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Safety of Riluzole in Patients With Acute Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT00876889
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : September 12, 2017
Sponsor:
Collaborators:
Christopher Reeve Paralysis Foundation
United States Department of Defense
AO Clinical Investigation and Documentation
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Robert G. Grossman, MD, The Methodist Hospital System

March 25, 2009
April 7, 2009
September 12, 2017
April 2010
June 2011   (Final data collection date for primary outcome measure)
American Spinal Injury Association Impairment Scale [ Time Frame: Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up ]
Neurological assessment and classification of spinal cord injury
Not Provided
Complete list of historical versions of study NCT00876889 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Other
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.
 
Completed
36
Same as current
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 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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00876889
Pro00002029
W81XWH-07-0042 ( Other Identifier: Department of Defense )
No
Not Provided
Not Provided
Robert G. Grossman, MD, The Methodist Hospital System
The Methodist Hospital System
  • Christopher Reeve Paralysis Foundation
  • United States Department of Defense
  • AO Clinical Investigation and Documentation
  • Ontario Neurotrauma Foundation
Study Chair: Robert G Grossman, MD The Methodist Hospital System
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
September 2017