Safety of Riluzole in Patients With Acute Spinal Cord Injury
NCT ID: NCT00876889
Last Updated: 2017-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2010-04-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Riluzole
50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days (28 doses).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to give written informed consent to participate in the study. The informed consent may require legally authorized representative to sign if arm/hand function is compromised.
* No other life-threatening injury
* Spinal cord injury at the neurologic level from C4 to T12
* ASIA Impairment Scale level A, B or C
* No cognitive impairment which would preclude an informed consent (including moderate or severe traumatic brain injury)
* Less than 12 hours since injury
Exclusion Criteria
* Hypersensitivity to riluzole or any of its components
* Unable to receive riluzole orally or via nasogastric tube
* History of liver or kidney disease (e.g. Hepatitis A, B or C, Cirrhosis, etc.)
* Has a recent history of regular substance abuse (illicit drugs, alcohol)
* Unconscious
* Penetrating spinal cord injury
* Pregnancy as established by urine pregnancy test
* Breastfeeding
* Life expectancy less than 12 months
* Is currently involved in another therapeutic SCI research study that precludes or complicates participation in this study (e.g. study of another therapeutic drug aiming for spinal cord injury recovery, any study that substantially interferes with the follow -up schedule (f/u) schedule, or any high risk study that complicates evaluation of safety outcomes. Types of studies that would not preclude participation are e.g. behavioral adaptation studies, mental health interventions)
* Has a mental disorder or other illness, which in the view of the site investigator, would preclude accurate evaluation (e.g. schizophrenia, severe cognitive disability, Parkinson disease)
* Unable to commit to the follow-up schedule
* Is a prisoner
* Unable to converse, read or write English at the elementary school level
18 Years
70 Years
ALL
No
Sponsors
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Christopher Reeve Paralysis Foundation
OTHER
United States Department of Defense
FED
AO Clinical Investigation and Publishing Documentation
OTHER
Ontario Neurotrauma Foundation
OTHER
The Methodist Hospital Research Institute
OTHER
Responsible Party
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Robert G. Grossman, MD
Professor, Department of Neurosurgery
Principal Investigators
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Robert G Grossman, MD
Role: STUDY_CHAIR
The Methodist Hospital Research Institute
Michael Fehlings, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto/Toronto Western Hospital, Toronto
Michele M Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
the University of Houston/Memorial HermannHospital, Houston
Christopher Shaffery, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Health System, Charlottesville
Susan Harkema, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville, Louisville
Bizhan Aarabi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland Medical Center, Baltimore
James Harrop, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University, Philadelphia
James Guest, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami, Miami
Ralph Frankowski, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas School of Public Health, Houston
Diana Chow, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Houston, College of Pharmacy, Houston
Locations
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University of Miami
Miami, Florida, United States
University of Louisville Health Sciences Center
Louisville, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
The Methodist Hospital
Houston, Texas, United States
The University of Texas
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
University of Toronto/Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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References
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Carroll AH, Fakhre E, Quinonez A, Tannous O, Mesfin A. An Update on Spinal Cord Injury and Current Management. JBJS Rev. 2024 Oct 24;12(10). doi: 10.2106/JBJS.RVW.24.00124. eCollection 2024 Oct 1.
Chow DS, Nguyen A, Park J, Wu L, Toups EG, Harrop JS, Guest JD, Schmitt KM, Aarabi B, Fehlings MG, Boakye M, Grossman RG. Riluzole in Spinal Cord Injury Study (RISCIS)-Pharmacokinetic (PK) Sub-Study: An Analysis of Pharmacokinetics, Pharmacodynamics, and Impact on Axonal Degradation of Riluzole in Patients With Traumatic Cervical Spinal Cord Injury Enrolled in the RISCIS Phase III Randomized Controlled Trial. J Neurotrauma. 2023 Sep;40(17-18):1889-1906. doi: 10.1089/neu.2022.0499.
Nagoshi N, Nakashima H, Fehlings MG. Riluzole as a neuroprotective drug for spinal cord injury: from bench to bedside. Molecules. 2015 Apr 29;20(5):7775-89. doi: 10.3390/molecules20057775.
Fehlings MG, Wilson JR, Frankowski RF, Toups EG, Aarabi B, Harrop JS, Shaffrey CI, Harkema SJ, Guest JD, Tator CH, Burau KD, Johnson MW, Grossman RG. Riluzole for the treatment of acute traumatic spinal cord injury: rationale for and design of the NACTN Phase I clinical trial. J Neurosurg Spine. 2012 Sep;17(1 Suppl):151-6. doi: 10.3171/2012.4.AOSPINE1259.
Chow DS, Teng Y, Toups EG, Aarabi B, Harrop JS, Shaffrey CI, Johnson MM, Boakye M, Frankowski RF, Fehlings MG, Grossman RG. Pharmacology of riluzole in acute spinal cord injury. J Neurosurg Spine. 2012 Sep;17(1 Suppl):129-40. doi: 10.3171/2012.5.AOSPINE12112.
Related Links
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The Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research, and improving the quality of life for people living with paralysis through grants, information and advocacy. Click here for more information about the network.
Other Identifiers
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W81XWH-07-0042
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00002029
Identifier Type: -
Identifier Source: org_study_id
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