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Trial record 10 of 299 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Riluzole in Spinal Cord Injury Study (RISCIS)

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ClinicalTrials.gov Identifier: NCT01597518
Recruitment Status : Recruiting
First Posted : May 14, 2012
Last Update Posted : March 12, 2018
AOSpine International
Christopher Reeve Paralysis Foundation
United States Department of Defense
Rick Hansen Institute
Information provided by (Responsible Party):
AOSpine North America Research Network

Brief Summary:
The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of patients with acute SCI. The primary objective is to 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 by International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) Motor Score, in patients with acute traumatic SCI, presenting to the hospital less than 12 hours after injury. Secondary objectives are to evaluate the effects of riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of life outcomes, health utilities, mortality, and adverse events. The working hypothesis is that 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Riluzole Drug: Placebo Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Placebo Controlled, Double-Blinded, Trial of Efficacy and Safety of Riluzole in Acute Spinal Cord Injury
Study Start Date : August 2013
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Riluzole
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo 2x in first 24 hours; Placebo 2x day 2--14
Experimental: Riluzole Drug: Riluzole
100mg BID first 24 hours after the injury; 50mg BID 2--14 days following the injury

Primary Outcome Measures :
  1. Change in ISNCSCI Total Motor Score between 180 days and baseline [ Time Frame: 180 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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*:


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597518

  Hide Study Locations
United States, Arizona
Barrow Neurological Institute Terminated
Phoenix, Arizona, United States, 85013
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: James D Guest, MD, PhD    305-243-7144    jguest@med.miami.edu   
Contact: George Jimsheleishvili    (305) 243-0126    gxj150@med.miami.edu   
Principal Investigator: James D Guest, MD, PhD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: Alaina Williams    404-778-1845    alaina.williams@emory.edu   
Principal Investigator: Faiz Ahmad, 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, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Maxwell Boakye, MD    502-581-8675    max.boakye@louisville.edu   
Contact: Lori J Clark    (502) 333-8140    LoriClark2@KentuckyOneHealth.org   
Principal Investigator: Maxwell Boakye, MD         
United States, Louisiana
Louisiana State University Recruiting
Baton Rouge, Louisiana, United States, 70803
Contact: Jason D. Wilson, MD, MS    504-568-2646    jwils8@lsuhsc.edu   
Contact: Erin S. Fannin, MSPH    504-568-2641    efanni@lsuhsc.edu   
Principal Investigator: Jason Wilson, MD, MS         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Bizhan Aarabi, MD    410-328-7371    baarabi@smail.umaryland.edu   
Contact: Charlene Aldrich, RN, MSN    (410) 328-5332    caldrich@som.umaryland.edu   
Principal Investigator: Bizhan Aarabi, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Audi Chokkalingam, CCRP    507-293-7392    Chokkalingam.Avudaiappan@mayo.edu   
Principal Investigator: Ahmad Nassr, MD         
United States, Missouri
University of Missouri Terminated
Columbia, Missouri, United States, 65212
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Linda Koester    314-362-7368    koesterl@wustl.edu   
Principal Investigator: 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   
Contact: Francis Quattrone    (215) 615-4587    francis.quattrone@uphs.upenn.edu   
Principal Investigator: James Schuster, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: James Harrop, MD    215-955-7000    james.harrop@jefferson.edu   
Contact: Patrick Maleszewski, MS       patrick.maleszewski@jefferson.edu   
Principal Investigator: James Harrop, MD         
United States, Texas
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Sven Hochheimer, MD    210-916-7624    sven.m.hochheimer.mil@mail.mil   
Contact: Amy E. Guthrie    (210) 275-8108    amy.e.guthrie.ctr@mail.mil   
Principal Investigator: Sven Hochheimer, MD         
UT Health Center Recruiting
Houston, Texas, United States, 77030
Contact: Karl M Schmitt, MD    713-704-7100    karl.schmitt@uth.tmc.edu   
Contact: Elena E Viverette    (713) 500-6230    elena.e.viverette@uth.tmc.edu   
Principal Investigator: Karl M Schmitt, 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   
Contact: Ashley Neese       ashley.neese@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: Judy Beenhakker, MS    (434) 982-1856    JGB3P@hscmail.mcc.virginia.edu   
Principal Investigator: Christopher Shaffrey, MD         
United States, Washington
Swedish Hospital Terminated
Seattle, Washington, United States, 98122
United States, Wisconsin
University of Wisconsin - Madison Recruiting
Madison, Wisconsin, United States, 53706
Contact: Nathaniel Brooks Brooks, MD    608-263-1410    n.brooks@neurosurgery.wisc.edu   
Contact: Stephanie Wilbrand    (608) 265-9248    s.wilbrand@neurosurgery.wisc.edu   
Principal Investigator: Nathaniel Brooks, MD         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Shekar Kurpad, MD    414-805-5978    skurpad@mcw.edu   
Contact: Charlotte Klis    (414) 805-7183    cklis@mcw.edu   
Principal Investigator: Shekar Kurpad, MD         
Australia, New South Wales
John Hunter Hospital Recruiting
Newcastle, New South Wales, Australia, 2310
Contact: Zsolt J. Balogh, MD, PhD    +61 2 4921 4259    zsolt.balogh@hnehealth.nsw.gov.au   
Contact: Kate King    +61 2 4921 4970    kate.king@hnehealth.nsw.gov.au   
Principal Investigator: Zsolt J. Balogh, MD, PhD         
Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Trent Li    +61 0430861828    trent.li@health.nsw.gov.au   
Principal Investigator: Ralph Stanford, MD         
Royal Rehab Active, not recruiting
Ryde, New South Wales, Australia, 2112
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Contact: Trent Li    +61 0430861828    trent.li@health.nsw.gov.au   
Principal Investigator: Jonathon Ball, MD         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Brian Freeman, MD    +61 882224466    brian.freeman@health.sa.gov.au   
Contact: James Swift    + 61 8 7074 1544    James.Swift@sa.gov.au   
Principal Investigator: Brian Freeman, MD         
Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Leilani Reichl    (604) 875 4111 ext 62853    Leilani.Reichl@vch.ca   
Principal Investigator: Brian K Kwon, MD,PhD         
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Albert Yee, MD    (416) 480-6815    albert.yee@sunnybrook.ca   
Contact: Aimee Theriault    (416) 480-4285    aimee.theriault@sunnybrook.ca   
Principal Investigator: Albert Yee, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5R 1C6
Contact: Kayee Tung, RN, CCRP    (416) 864-6060    TungK@smh.ca   
Principal Investigator: Jefferson Wilson, MD         
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         
New Zealand
Middlemore Hospital Not yet recruiting
Otahuhu, Auckland, New Zealand, 2025
Contact: Alpesh Patel, MD    +64 9 276 0000    alpesh.patel@middlemore.co.nz   
Contact: Jo Nunnerley    +64 3 383 6871    jo.nunnerley@burwood.org.nz   
Principal Investigator: Alpesh Patel, MD         
Christchurch Hospital Not yet recruiting
Christchurch, New Zealand, 8011
Contact: Kris Dalzell, MD    +64 3 365 3376    kristian.dalzell@cdhb.health.nz   
Contact: Jo Nunnerley    +64 3 383 6871    jo.nunnerley@burwood.org.nz   
Principal Investigator: Kris Dalzell, MD         
Sponsors and Collaborators
AOSpine North America Research Network
AOSpine International
Christopher Reeve Paralysis Foundation
United States Department of Defense
Rick Hansen Institute
Principal Investigator: Michael Fehlings, MD, PhD University Health Network, Toronto, Canada
Study Director: Branko Kopjar, MD PhD University of Washington

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AOSpine North America Research Network
ClinicalTrials.gov Identifier: NCT01597518     History of Changes
Other Study ID Numbers: SPN-12-001
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Keywords provided by AOSpine North America Research Network:
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
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents