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

Inclusion criteria

• Age between 18 and 80 years
• Diagnosis of symptomatic cervical spondylotic myelopathy defined as a combination of:

• one or more of the following symptoms:

• Numb hands
• Clumsy hands
• Impairment of gait
• Bilateral arm paresthesiae
• l'Hermitte's phenomena
• Weakness And,
• one or more of the following signs:

• Corticospinal distribution motor deficits
• Atrophy of hand intrinsic muscles
• Hyperreflexia
• Positive Hoffman sign
• Upgoing plantar responses
• Lower limb spasticity
• Broad based, unstable gait And,
• MRI evidence of cervical spondylotic myelopathy
• Scheduled for an elective surgery for cervical spondylotic myelopathy
• Preoperative mJOA score ≥8 and ≤14
• Women of child bearing potential must be:

• Postmenopausal defined as amenorrhea for at least 2 years.
• Surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
• Abstinent (at the discretion of the investigator)
• Having other congenital or medical condition that prevents subject from becoming pregnant
• If sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, intrauterine device (IUD), or male partner with a vasectomy. A double-barrier method such as condoms, diaphragms or cervical caps with spermicidal foam, cream or gel may be used as a birth control method.
• Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test or a negative urine pregnancy test at screening before the first dose of study drug is received.

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