Ensayos clínicos

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