A clinical study of the safety and efficacy of anti-epileptic drug Zonisamide for treatment of radiculopaty

JRCT ID: jRCTs041210043

Registered date:21/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cervical spondylotic radiculopathy
• Date of first enrollment: 27/01/2022
• Target sample size: 24
• Study type: Interventional

Intervention(s)

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
arm high-dose: Zonisamide (100mg) once a day every day for one week. When we detect the absence of CTCAE grade 3 or higher adverse events, 100mg three times a day until 84 days
arm highest-dose: Zonisamide (100mg) once a day every day for one week. When we detect the absence of CTCAE grade 3 or higher adverse events, 200mg three times a day until 84 days

Outcome(s)

• Primary Outcome: 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 Outcome: pain detect Questionnaire, SF36, JOA, NRS, NCV

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 640age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Imagama Shiro
• Secondary ID(s): Nil known