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Trial record 1 of 1 for:    NCT00876889
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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
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

Brief 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).

Condition or disease Intervention/treatment
Spinal Cord Injury Drug: Riluzole

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.

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury
Study Start Date : April 2010
Primary Completion Date : June 2011
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Riluzole
U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. 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

Biospecimen Retention:   Samples Without DNA
plasma and cerebral spinal fluid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Admitted to a NACTN hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876889

United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Kentucky
University of Louisville Health Sciences Center
Louisville, Kentucky, United States, 40205
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
The University of Texas
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Canada, Ontario
University of Toronto/Toronto Western Hospital
Toronto, Ontario, Canada, M5T-2S8
Sponsors and Collaborators
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert G. Grossman, MD, Professor, Department of Neurosurgery, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT00876889     History of Changes
Other Study ID Numbers: Pro00002029
W81XWH-07-0042 ( Other Identifier: Department of Defense )
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by Robert G. Grossman, MD, The Methodist Hospital System:
spinal cord injury
Acute Traumatic Spinal Cord Injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents