Safety of Riluzole in Patients With Acute Spinal Cord Injury

NCT00876889 | Completed

• 2 other identifiers: Pro00002029W81XWH-07-0042
• Study Type: observational
• Target: 36
• Locations: 2 countries
• Sites: 8

Brief Summary

The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI).

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; riluzole; pharmacokinetics; Acute Traumatic Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• American Spinal Injury Association Impairment Scale

  Neurological assessment and classification of spinal cord injury

  Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up

Interventions

Riluzole DRUG

50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days (28 doses).

Also known as: Rilutek

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Admitted to a NACTN hospital

You may qualify if:

• Age equal to or greater than 18 years and less than or equal to 70 years;
• 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

You may not qualify if:

• Equal or more than 12 hours since injury
• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Christopher Reeve Paralysis Foundation: collaborator
• United States Department of Defense: collaborator
• AO Clinical Investigation and Publishing Documentation: collaborator
• Ontario Neurotrauma Foundation: collaborator

Study Sites (8)

University of Miami

Miami, Florida, 33136, United States

Location

University of Louisville Health Sciences Center

Louisville, Kentucky, 40205, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

The University of Texas

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

University of Toronto/Toronto Western Hospital

Toronto, Ontario, M5T-2S8, Canada

Location

Related Publications (5)

• 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.

  PMID: 39446982 DERIVED

• 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.

  PMID: 37130044 DERIVED

• 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.

  PMID: 25939067 DERIVED

• 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.

  PMID: 22985381 DERIVED

• 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.

  PMID: 22985379 DERIVED

Related Links

• 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and cerebral spinal fluid

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert G Grossman, MD

  The Methodist Hospital Research Institute

  STUDY CHAIR

• Michael Fehlings, MD, PhD

  University of Toronto/Toronto Western Hospital, Toronto

  PRINCIPAL INVESTIGATOR

• Michele M Johnson, MD

  the University of Houston/Memorial HermannHospital, Houston

  PRINCIPAL INVESTIGATOR

• Christopher Shaffery, MD

  University of Virginia Health System, Charlottesville

  PRINCIPAL INVESTIGATOR

• Susan Harkema, PhD

  University of Louisville, Louisville

  PRINCIPAL INVESTIGATOR

• Bizhan Aarabi, MD

  University of Maryland Medical Center, Baltimore

  PRINCIPAL INVESTIGATOR

• James Harrop, MD

  Thomas Jefferson University, Philadelphia

  PRINCIPAL INVESTIGATOR

• James Guest, MD, PhD

  University of Miami, Miami

  PRINCIPAL INVESTIGATOR

• Ralph Frankowski, PhD

  The University of Texas School of Public Health, Houston

  PRINCIPAL INVESTIGATOR

• Diana Chow, PhD

  University of Houston, College of Pharmacy, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neurosurgery

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: April 7, 2009
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: April 1, 2012
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

US (7); CA (1)