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:

1. one or more of the following symptoms:

- Numb hands

- Clumsy hands

- Impairment of gait

- Bilateral arm paresthesiae

- l'Hermitte's phenomena

- Weakness And,

2. 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,

3. 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