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

Phase 1

Recruiting

• Conditions: Cervical spondylotic radiculopathy; Cervical spondylotic radiculopathy, cervical disc hernia, sensory impairment; D011843

• Registration Number: JPRN-jRCTs041210043
• Lead Sponsor: Imagama Shiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified