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

• Nurick Score [ Time Frame: Pre-surgical, 180 days ]
  Nurick score is a simple measure of neurological dysfunction and ranges from 0 (best) to 6 (worst).
• SF-36v2.0 [ Time Frame: Before the surgery, 180 days ]
  The SF36v2.0 is a health-related quality of life instrument that evaluates health status accross eight health dimensions.
• Neck Disability Index (NDI) [ Time Frame: Before the surgery, 180 days ]
  The NDI evaluates patient self-reported functional outcomes related to neck conditions. The NDI score ranges from 0 (best) to 100 (worst).
• Cervical Pain Numeric Rating Scale [ Time Frame: Before the surgery, 180 days ]
  Simple numeric rating scale with choises of answers from 0 (no pain) to 10 (worst imaginable pain)
• EQ-5D [ Time Frame: Before the surgery, 180 days ]
  EQ-5D™ is a standardised instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status.
• American Spinal Injury Association Score (ASIA) [ Time Frame: Before the surgery, 180 days ]
  The ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury.

• Nurick Score [ Time Frame: Pre-surgical, 180 days ]
  Nurick score is a simple measure of neurological dysfunction and ranges from 0 (best) to 6 (worst).
• SF-36v2.0 [ Time Frame: Before the surgery, 180 days ]
  The SF36v2.0 is a health-related quality of life instrument that evaluates health status accross eight health dimensions.
• Neck Disability Index (NDI) [ Time Frame: Before the surgery, 180 days ]
  The NDI evaluates patient self-reported functional outcomes related to neck conditions. The NDI score ranges from 0 (best) to 100 (worst).
• Cervical Pain Numeric Rating Scale [ Time Frame: Before the surgery, 180 days ]
  Simple numeric rating scale with choises of answers from 0 (no pain) to 10 (worst imaginable pain)
• EQ-5D [ Time Frame: Before the surgery, 180 days ]
  EQ-5D™ is a standardised instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status.
• sia American Spinal Injury Association Score (ASIA) [ Time Frame: Before the surgery, 180 days ]
  The ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury.

• Drug: riluzole
  50mg BID orally for 14 days prior to surgery and 28 days after the surgery
  Other Name: Rilutek
• Drug: Placebo medication
  50mg BID orally for 14 days prior to surgery and 28 days after the surgery

• Placebo Comparator: Placebo
  Placebo medication and decompressive cervical spine surgery
  Intervention: Drug: Placebo medication
• Experimental: Riluzole
  Riluzole in dose 50mg BID for 14 days prior to surgery and 28 days after the decompressive spine surgery
  Intervention: Drug: riluzole

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