Clinical trial NCT00876889: Safety of Riluzole in Patients With Acute Spinal Cord Injury
Official title: Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
riluzole
pharmacokinetics
Acute Traumatic Spinal Cord Injury
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Christopher Reeve Paralysis Foundation
name: United States Department of Defense
name: AO Clinical Investigation and Publishing Documentation
name: Ontario Neurotrauma Foundation
First posted: 2009-04-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted to a NACTN hospital

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).

Detailed description: The primary aim of the study is to develop acute care safety and pharmacokinetic profiles of riluzole in patients who have sustained a acute traumatic spinal cord injury. Secondary objectives are to conduct exploratory analyses of functional outcomes for purposes of planning a subsequent Phase II randomized study of the efficiency of Riluzole for the treatment of acute traumatic spinal cord injury.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: American Spinal Injury Association Impairment Scale
timeFrame: Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Louisville
country: United States
facility: University of Louisville Health Sciences Center
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Toronto
country: Canada
facility: University of Toronto/Toronto Western Hospital
state: Ontario
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Robert G Grossman, MD
role: STUDY_CHAIR
affiliation: University of Toronto/Toronto Western Hospital, Toronto
name: Michael Fehlings, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: the University of Houston/Memorial HermannHospital, Houston
name: Michele M Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia Health System, Charlottesville
name: Christopher Shaffery, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville, Louisville
name: Susan Harkema, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland Medical Center, Baltimore
name: Bizhan Aarabi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University, Philadelphia
name: James Harrop, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami, Miami
name: James Guest, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas School of Public Health, Houston
name: Ralph Frankowski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Houston, College of Pharmacy, Houston
name: Diana Chow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.