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
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Chemotherapy-induced polyneuropathy
- 发起方
- eids Universitair Medisch Centrum
- 入组人数
- 110
- 状态
- 招募中
- 最后更新
- 去年
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 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
结局指标
主要结局
未指定
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