NL-OMON52883招募中4 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 study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 110
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
- 18 至 64（—）
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 4 or higher
- •5. Chemotherapy with taxanes, platinums, vincalkinioids or bortezomib in the
- •6. Presence of symptoms of neuropathic pain at least 3 months after the last
- •chemotherapy
排除标准
- •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
- •12. Heart Rhythm Disorders (including 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
研究者
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