Riluzole in Spinal Cord Injury Study (RISCIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by AOSpine North America Research Network
Sponsor:
Collaborator:
AOSpine International
Information provided by (Responsible Party):
AOSpine North America Research Network
ClinicalTrials.gov Identifier:
NCT01597518
First received: May 10, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Spinal Cord Injury
Drug: Riluzole
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by AOSpine North America Research Network:

Primary Outcome Measures:
  • Change in ISNCSCI Total Motor Score between 180 days and baseline [ Time Frame: 180 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 351
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION:

  • 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

EXCLUSION:

  • 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
  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: NCT01597518

Locations
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 Not yet 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         
Sponsors and Collaborators
AOSpine North America Research Network
AOSpine International
Investigators
Principal Investigator: Michael Fehlings, MD, PhD University Health Network, Toronto, Canada
Study Director: Branko Kopjar, MD PhD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: AOSpine North America Research Network
ClinicalTrials.gov Identifier: NCT01597518     History of Changes
Other Study ID Numbers: SPN-12-001
Study First Received: May 10, 2012
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by AOSpine North America Research Network:
Riluzole
spinal cord injury
treatment

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 20, 2014