IRCT20090613002027N21招募中2 期
Evaluation of the efficacy and safety of the addition of lacosamide to duloxetine in the treatment of taxanes- induced peripheral neuropathy: a randomized double-blind placebo-controlled trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
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 years 至 no limit（—）
- 性别
- All
入选标准
- •People aged 18 years and older
- •Patients with taxane-induced peripheral neuropathy
- •Existence of moderate to severe neuropathic pain with PI-NRS score =4
- •Normal baseline ECG
排除标准
- •Patients with a history of neurological diseases such as hereditary or acquired neuropathies
- •Patients with neuropathic pain due to conditions such as post-herpes neuralgia, uncontrolled diabetes with neuropathy, trigeminal neuralgia, spinal cord injury or other neurological diseases, known vitamin B12 deficiency, amyloidosis, neuromuscular diseases and connective tissue diseases
- •Creatinine clearance less than 30 ml / min
- •Severe liver failure
- •History of allergy to lacosamide or duloxetine
- •History of duloxetine or lacosamide use
- •Evidence of severe systemic disease
- •patients with epilepsy
- •Drugs that interact with the study drugs including tricyclic antidepressants (TCAs), norepinephrine-specific serotonin reuptake inhibitors (SNRIs), and sodium channel blockers in the past three months
- •Use of monoamine oxidase inhibitors (MAOIs) in the last fourteen days or simultaneously
- •Drugs that interact with the study drugs including atazanavir, siponimod, carbamazepine, phenobarbital, phenytoin, amiodarone, sotalol, antiarrhythmic drugs that increase QT interval, including class IA and IC, beta-blockers and non-dihydropyridine calcium channel blockers, lidocaine, and mexiletine
- •Pregnant or lactating women
- •Dissatisfaction with participating in the study
研究者
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