Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect)

Exclusion Criteria

• •Previous surgery for CSM
• •Concomitant symptomatic lumbar stenosis
• •CSM symptoms due to cervical trauma (at the discretion of the investigator)
• •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 milligrams per deciliter in females at screening visit Liver enzymes (ALT or AST) 3x higher than normal values at screening visit.
• •Liver enzymes (ALT or AST) 3x higher than normal values at screening visit.
• •Subject will be using any of the following medications which are classified as CYP1A2 inhibitors or inducers\*during the course of the drug regimen:
• •Inhibitors:
• •Ciprofloxacin
• •Enoxacin
• •Fluvoxamine
• •Methoxsalen
• •Mexiletine
• •Oral contraceptives
• •Phenylpropanolamine
• •Thiabendazole
• •Zileuton
• •Inducers:
• •Montelukast
• •Phenytoin
• •\*Note: no washout period required; if these medications are discontinued, subjects are eligible to be enrolled in the trial.
• •Systemic infection such as AIDS, HIV, and active hepatitis
• •Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years
• •Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation
• •Breastfeeding at screening visit and plan to continue during the course of the study drug
• •Unlikely to comply with the follow-up evaluation schedule
• •Unlikely to comply with investigational drug regime
• •Participation in a clinical trial of another investigational drug or device within the past 30 days
• •Is a prisoner
• •Unable to converse, read or write English at elementary school level