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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 : June 6, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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

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Study Design

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 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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


Outcome Measures

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

Eligibility Criteria

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
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

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


  Show 26 Study Locations
Sponsors and Collaborators
AOSpine North America Research Network
AOSpine International
Christopher Reeve Paralysis Foundation
United States Department of Defense
Rick Hansen Institute
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:
Publications:

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: June 6, 2017
Last Verified: June 2017

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
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents