EUCTR2020-001285-11-NL
进行中（未招募）
1 期
A Randomized, open label, Non-inferiority trial on the efficacy of Lacosamide versus Duloxetine in Patients with Chemotherapy-induced Polyneuropathy – A strategy trial - LAX
eiden University Medical Center0 个研究点目标入组 100 人2020年11月13日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- eiden University Medical Center
- 入组人数
- 100
- 状态
- 进行中（未招募）
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Age\> 18 years
- •2\.Able to give oral and written informed consent
- •3\.Presence of CIPN grade 1 or higher according to the NCIC\-CTC
- •4\.Pain score of 45 or higher
- •5\.Chemotherapy with taxanes, platinums, vincalkinioids or bortezomib in the last 2 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 60
- •F.1\.3 Elderly (\>\=65 years) yes
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study
- •1\.Allergy to the study medication
- •2\.Epilepsy
- •3\.History of illicit drug or alcohol abuse
- •4\.History of psychosis
- •5\.Pregnancy or lactation
- •6\.Use of anti\-epileptic or anti\-depressant medication
- •7\.Concomittant neuropathy other than chemotherapy\-induced
- •8\.Moderate and severe liver enzyme abnormalities
- •9\.Kidney dysfunction (GFR \< 30 mL/min)
结局指标
主要结局
未指定
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