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Safety of Riluzole in Patients With Acute Spinal Cord Injury
This study is not yet open for participant recruitment.
Verified by The Methodist Hospital System, April 2009
First Received: March 25, 2009   Last Updated: April 6, 2009   History of Changes
Sponsors and Collaborators: The Methodist Hospital System
Christopher Reeve Paralysis Foundation
The University of Texas Health Science Center, Houston
University of Virginia
University of Louisville
University of Toronto
University of Maryland
Thomas Jefferson University
University of Miami
Information provided by: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT00876889
  Purpose

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 spinal cord injury (SCI).


Condition Intervention
Spinal Cord Injury
Drug: Riluzole

MedlinePlus related topics: Spinal Cord Injuries
Drug Information available for: Riluzole
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury

Further study details as provided by The Methodist Hospital System:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

plasma and cerebral spinal fluid


Estimated Enrollment: 36
Study Start Date: May 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Riluzole
    50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days.
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 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 spinal cord injury.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Admitted to a NACTN hospital

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876889

Contacts
Contact: Elizabeth Toups, MS, RN 713-441-3897 etoups@tmhs.org

Locations
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
The University of Texas Health Science Center, Houston
University of Virginia
University of Louisville
University of Toronto
University of Maryland
Thomas Jefferson University
University of Miami
Investigators
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: Christopher Shields, MD University of Louisville, Louisville
Principal Investigator: Bizhan Aarabi, MD University of Maryland Medical Center, Baltimore
Principal Investigator: James Harrop, MD Thomas Jefferson University
Principal Investigator: James Guest, MD, PhD University of 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
Principal Investigator: Branko Kopjar, MD, PhD University of Washington, School of Public Health, Seattle
  More Information

Additional Information:
No publications provided

Responsible Party: The Methodist Hospital System ( Robert G. Grossman, MD )
Study ID Numbers: 00002029, W81XWH-07-1-0361
Study First Received: March 25, 2009
Last Updated: April 6, 2009
ClinicalTrials.gov Identifier: NCT00876889     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by The Methodist Hospital System:
spinal cord injury
riluzole
pharmacokinetics
Acute Traumatic Spinal Cord Injury

Study placed in the following topic categories:
Riluzole
Excitatory Amino Acids
Spinal Cord Injuries
Neurotransmitter Agents
Spinal Cord Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Neuroprotective Agents
Anticonvulsants

Additional relevant MeSH terms:
Riluzole
Neurotransmitter Agents
Spinal Cord Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Excitatory Amino Acid Agents
Trauma, Nervous System
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Spinal Cord Injuries
Therapeutic Uses
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on May 07, 2009