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 人开始时间: 2020年11月13日最近更新: 2023年2月20日

试验速览

暂无简介。

•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
•F.1.3.1 Number of subjects for this age range 40

•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)
•10.Severe heart failure
•11.Any condition that by the judgement of the investigator might interfere with the investigation

发起方

eiden University Medical Center