A Randomized, Open label, trial on the efficacy of Lacosamide versus Duloxetine in Patients with Chemotherapy-induced Polyneuropathy – A strategy trial

MC0 个研究点目标入组 110 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•1. Age> 18 years
•2. Able to give oral and written informed consent
•3. Indications of small- or large fiber neuropathy with quantitative sensory testing (compared to healthy population)
•4. Pain score of 4 or higher
•5. Chemotherapy with taxanes, platinums, vincalkinioids or bortezomib in the past
•6. Presence of symptoms of neuropathic pain for at least 6 months after the last chemotherapy

•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 (in particular MAO inhibitors)
•7. Use of CYP1a2 inhibitors (e.g. fluvoxamine, fluocinolone, cimetidine)
•8. Concomitant neuropathy other than chemotherapy-induced
•9. Moderate and severe liver enzyme abnormalities
•10. Kidney dysfunction (GFR < 30 mL/min)
•11. Severe heart failure (e.g. as a result of infarction or a structural heart defect)
•12. 2nd or 3rd degree atrioventricular (AV) block and sodium channelopathies.
•13. Systolic blood pressure above 180mm Hg with current antihypertensive medications (according to screening measurement)
•14. Any condition that by the judgement of the investigator might interfere with the investigation

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