SHS_543092 CHAJ NAOS 15117

A Multi-Center, Randomized, Placebo Controlled, Double-Blinded, Trial of Efficacy and Safety of Riluzole in Acute Spinal Cord Injury (RISCIS)

Evaluate the efficacy and safety of riluzole in the treatment of patients with acute spinal cord injury.

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
Phase II/III
NCT01597518
Neurosciences
Spine
Jens Chapman, M.D.
AOSpine
xCarol Kemp
  • Swedish Medical Center