Riluzole in Spinal Cord Injury Study

Who May Be a Candidate

Illustration of Spinal Cord and NervesMen and women age 18 through 75 years of age with neurological injury between C4-C8 based upon first International Standards For Neurological Classification of Spinal Cord Injury (ISNCSCI) evaluation after arrival to the hospital, and who are able to receive the Investigation Drug with 12 hours of spinal cord injury (SCI). Candidates for this clinical trial must meet other inclusion criteria.

Clinical Trial Sponsor

This clinical trial is sponsored by AOSpine North America Research Network.

Purpose and Objective

The purpose of this study is to evaluate efficacy and safety of riluzole in the treatment of patients with acute spinal cord injury.

Primary Objective: Evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after injury, as compared to placebo, in change between 180 days and baseline in motor outcomes as measured byISNCSCI Motor Score, in patients with acute traumatic SCI, presenting to the hospital less than 12 hours after injury.

Secondary Objectives: Evaluate the effects of riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of life outcomes, health utilities, mortality, and adverse events.

Working Hypothesis: The riluzole treated subjects will experience superior motor, sensory, functional, and quality of life outcomes as compared to those receiving placebo, with an acceptable safety profile.

Recruiting Locations (United States and Canada)

United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Nicholas Theodore, MD    602-406-6335   
Principal Investigator: Nicholas Theodore, MD         
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Paul Arnold, MD    913-558-7587   
Contact: Linda Jianas    913-558-3252   
Principal Investigator: Paul Arnold, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Bizhan Aarabi, MD    410-328-7371   
Principal Investigator: Bizhan Aarabi, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ahmad Nassr, MD    507-284-2511   
Principal Investigator: Ahmad Nassr, MD         
United States, Missouri
Washington University Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: W. Zack Ray, MD    314-362-9959   
Principal Investigator: W. Zack Ray, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: James Schuster, MD    215-615-4587   
Principal Investigator: James Schuster, MD         
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: James Harrop, MD    215-955-7000   
Principal Investigator: James Harrop, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Darrel Brodke, MD    801-587-5450   
Principal Investigator: Darrel Brodke, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Christopher Shaffrey, MD    434-243-9728   
Contact: Jenny De Jong, RN, BSN    434-243-9986   
Principal Investigator: Christopher Shaffrey, MD         
Canada, Ontario
University of Toronto Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Michael Fehlings, MD    (416) 603-5627   
Contact: Yuriy Petrenko, MD    (416) 603-5285   
Principal Investigator: Michael Fehlings, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5R 1C6
Contact: Henry Ahn, MD    416-864-6005   
Contact: Kayee Tung, RN, CCRP    416-864-6060 ext 2713   
Principal Investigator: Henry Ahn, MD         

Eligibility, Inclusion and Exclusion Criteria

Inclusion Criteria:
  1. Age between 18 and 75 years inclusive
  2. Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (includes patients who are on a ventilator)
  3. Willing and able to comply with the study Protocol
  4. Signed Informed Consent Document (ICD) by patient, legal representative or witness
  5. Able to receive the Investigational Drug within 12 hours of injury
  6. ISNCSCI Impairment Scale Grade "A," "B" or "C" based upon first ISNCSCI evaluation after arrival to the hospital
  7. Neurological Level of Injury between C4-C8 based upon first ISNCSCI evaluation after arrival to the hospital
  8. Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test or a negative urine pregnancy test

* Additional inclusion/exclusion criteria apply. Please consult with your physician to review the complete eligibility criteria.

Exclusion Criteria:

  1. Injury arising from penetrating mechanism
  2. Significant concomitant head injury defined by a Glasgow Coma Scale score < 14 with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator)
  3. Pre-existent neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia)
  4. Previous history of spinal cord injury
  5. Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator
  6. Is a prisoner
  7. Participation in a clinical trial of another Investigational Drug or Investigational Device within the past 30 days
  8. Hypersensitivity to riluzole or any of its components
  9. Neutropenia measured as absolute neutrophil count (ANC) measured in cells per microliter of blood of < 1500 at screening visit
  10. Creatinine level of > 1.2 milligrams (mg) per deciliter (dL) in males or > 1.1 mg per dL in females at screening visit
  11. Liver enzymes (ALT/SGPT or AST/SGOT) 3 times the upper limit of normal (ULN) at screening visit
  12. Active liver disease or clinical jaundice
  13. Acquired immune deficiency syndrome (AIDS) or AIDS-related complex
  14. Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study
  15. Lactating at screening visit
  16. Subject is currently using, and will continue to use for the next 14 days any of the following medications which are classified as CYP1A2 inhibitors or inducers*:


  • Ciprofloxacin
  • Enoxacin
  • Fluvoxamine
  • Methoxsalen
  • Mexiletine
  • Oral contraceptives
  • Phenylpropanolamine
  • Thiabendazole
  • Zileuton


  • Montelukast
  • Phenytoin

    • Note: no washout period required; if these medications are discontinued, subjects are eligible to be enrolled in the trial

* Additional inclusion/exclusion criteria apply. Please consult with your physician to review the complete eligibility criteria.


Updated on: 01/12/16