Riluzole in Spinal Cord Injury Study
Who May Be a Candidate
Men 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 Nicholas.Theodore@bnaneuro.net | |
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 parnold@kumc.edu | |
Contact: Linda Jianas 913-558-3252 ljianas@kumc.edu | |
Principal Investigator: Paul Arnold, MD | |
United States, Maryland | |
University of Maryland | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Bizhan Aarabi, MD 410-328-7371 baarabi@smail.umaryland.edu | |
Principal Investigator: Bizhan Aarabi, MD | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Ahmad Nassr, MD 507-284-2511 nassr.ahmad@mayo.edu | |
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 rayz@wudosis.wustl.edu | |
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 schustej@uphs.upenn.edu | |
Principal Investigator: James Schuster, MD | |
Rothman Institute | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: James Harrop, MD 215-955-7000 james.harrop@jefferson.edu | |
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 darrel.brodke@hsc.utah.edu | |
Principal Investigator: Darrel Brodke, MD | |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Christopher Shaffrey, MD 434-243-9728 CIS8Z@hscmail.mcc.virginia.edu | |
Contact: Jenny De Jong, RN, BSN 434-243-9986 JAD5YC@hscmail.mcc.virginia.edu | |
Principal Investigator: Christopher Shaffrey, MD | |
Canada, Ontario | |
University of Toronto Hospital | Recruiting |
Toronto, Ontario, Canada, M5T 2S8 | |
Contact: Michael Fehlings, MD (416) 603-5627 Michael.Fehlings@uhn.on.ca | |
Contact: Yuriy Petrenko, MD (416) 603-5285 yuriy.petrenko@uhn.on.ca | |
Principal Investigator: Michael Fehlings, MD | |
St. Michael's Hospital | Not yet recruiting |
Toronto, Ontario, Canada, M5R 1C6 | |
Contact: Henry Ahn, MD 416-864-6005 AhnH@smh.ca | |
Contact: Kayee Tung, RN, CCRP 416-864-6060 ext 2713 TungK@smh.ca | |
Principal Investigator: Henry Ahn, MD |
Eligibility, Inclusion and Exclusion Criteria
- Age between 18 and 75 years inclusive
- Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (includes patients who are on a ventilator)
- Willing and able to comply with the study Protocol
- Signed Informed Consent Document (ICD) by patient, legal representative or witness
- Able to receive the Investigational Drug within 12 hours of injury
- ISNCSCI Impairment Scale Grade "A," "B" or "C" based upon first ISNCSCI evaluation after arrival to the hospital
- Neurological Level of Injury between C4-C8 based upon first ISNCSCI evaluation after arrival to the hospital
- 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:
- Injury arising from penetrating mechanism
- 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)
- 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)
- Previous history of spinal cord injury
- 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
- Is a prisoner
- Participation in a clinical trial of another Investigational Drug or Investigational Device within the past 30 days
- Hypersensitivity to riluzole or any of its components
- Neutropenia measured as absolute neutrophil count (ANC) measured in cells per microliter of blood of < 1500 at screening visit
- Creatinine level of > 1.2 milligrams (mg) per deciliter (dL) in males or > 1.1 mg per dL in females at screening visit
- Liver enzymes (ALT/SGPT or AST/SGOT) 3 times the upper limit of normal (ULN) at screening visit
- Active liver disease or clinical jaundice
- Acquired immune deficiency syndrome (AIDS) or AIDS-related complex
- 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
- Lactating at screening visit
- 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*:
Inhibitors:
- Ciprofloxacin
- Enoxacin
- Fluvoxamine
- Methoxsalen
- Mexiletine
- Oral contraceptives
- Phenylpropanolamine
- Thiabendazole
- Zileuton
Inducers:
- 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.