Cervical spondylotic radiculopathy Cervical spondylotic radiculopathy, cervical disc hernia, sensory impairment
Conditions
Interventions
arm low-dose: Zonisamide (50mg) once a day every day, take it every day for 84 days until 84 days
arm middle-dose: Zonisamide (100mg) once a day every day, take it every day for 84 days until 84 days
Zonisamide, Mecobalamin, open-label
Sponsors
Imagama Shiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) First diagnosed by a spine surgeon as cervical spondylotic radiculopathy in Nagoya University or 7 Nagoya University-affiliated hospitals. 2) Age was between 20 and 64 years old. 3) A performance status (PS) score 0 to 3 4)adequate organ function: 1. AST: the upper limit of the facility reference value < 5 times 2. ALT: the upper limit of the facility reference value < 5 times 3. Total bilirubin: the upper limit of the facility standard value < 3 times 4. Serum creatinine: the upper limit of the facility's reference value < 3 times 5. No other events which make administration of the study drug difficult will not occurred. 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Other neurological diseases 2) Currently taking Zonisamide or has been taking it for less than a year 3) Malignant tumor 4) Active infection 5) Severe psychological disorder or severe neurological impairment 6) Grade 3 or higher (CTCAE v5.0) or abnormal laboratory values 7) Pregnant 8) Patients who are deemed ineligible by the Doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events, incidence rate of serious adverse events, blood test before and 28 days , 56 days and 84 days after medication, chest Xray before and 28 days and 84 days after medication | — |
Secondary
| Measure | Time frame |
|---|---|
| pain detect Questionnaire, SF36, JOA, NRS, NCV | — |
Contacts
Public ContactHiroaki Nakashima
Orthopedic Surgery
Outcome results
None listed