Safety of Riluzole in Patients With Acute Spinal Cord Injury

September 11, 2017 updated by: Robert G. Grossman, MD, The Methodist Hospital Research Institute

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Admitted to a NACTN hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Methodist Hospital Research Institute

Collaborators

United States Department of Defense
AO Clinical Investigation and Publishing Documentation
Ontario Neurotrauma Foundation
Christopher Reeve Paralysis Foundation

Investigators

  • Study Chair: Robert G Grossman, MD, The Methodist Hospital Research Institute
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (ESTIMATE)

April 7, 2009

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00002029
  • W81XWH-07-0042 (OTHER: Department of Defense)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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