Riluzole - Acute Spinal Cord Injury

Overview

Status: Enrolling by invitation
Keywords: Spinal Cord Injury , SCI , Riluzole
IRB Number: 00065748
Specialty: Orthopaedic Surgery, Orthopaedic Surgery, Orthopaedic Surgery
Sub Specialties: Orthopaedic Trauma, Spine Surgery

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 100mg the 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 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 everall 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.

Principal Investigator: Darrel Brodke
Department: Orthopedic Surgery
Co Investigator: Brandon Lawrence

Contact Information

Name:Ashley Woodbury
Phone: 801-339-2710
Email: Ashley.Neese@hsc.utah.edu

Inclusion Criteria

 

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 Criteria

 

 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

 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:

o Ciprofloxacin

o Enoxacin

o Fluvoxamine

o Methoxsalen

o Mexiletine

o Oral contraceptives

o Phenylpropanolamine

o Thiabendazole

o Zileuton

Inducers:

o Montelukast

o Phenytoin

*Note: no washout period required; if these medications are discontinued, subjects are eligible to be enrolled in the trial

 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