Safety of Riluzole in Patients With Acute Spinal Cord Injury

This study has been completed.
Sponsor:
Collaborators:
Christopher Reeve Paralysis Foundation
AO Clinical Investigation and Documentation
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Robert G. Grossman, MD, The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00876889
First received: March 25, 2009
Last updated: July 29, 2013
Last verified: July 2013
  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 traumatic spinal cord injury (SCI).


Condition Intervention
Spinal Cord Injury
Drug: Riluzole

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • American Spinal Injury Association Impairment Scale [ Time Frame: Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up ] [ Designated as safety issue: No ]
    Neurological assessment and classification of spinal cord injury


Biospecimen Retention:   Samples Without DNA

plasma and cerebral spinal fluid


Enrollment: 36
Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: June 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 (28 doses).
    Other Name: Rilutek
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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
AO Clinical Investigation and Documentation
Ontario Neurotrauma Foundation
Investigators
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
  More Information

Additional Information:
No publications provided by The Methodist Hospital System

Additional 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: 00002029, W81XWH-07-0042
Study First Received: March 25, 2009
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014