JPRN-jRCTs041210043招募中1 期
A clinical study of the safety and efficacy of anti-epileptic drug Zonisamide for treatment of radiculopaty
Imagama Shiro0 个研究点目标入组 24 人开始时间: 2021年7月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 640age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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