EUCTR2019-001260-29-DK进行中（未招募）1 期
Proof of concept study for evaluation of the effect of ketamine intranasal spray in treatment of chronic Cluster Headache (CCH)
CCH Pharmaceuticals0 个研究点目标入组 20 人开始时间: 2019年6月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed informed consent
- •Age between 18 and 60 years
- •Diagnose: Chronic cluster headache according to ICHD-3 criteria
- •Body weight =50 kg and BMI =30
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Conditions that result in the participant being unable to complete the experiment
- •Medical history with elevated intraocular pressure (e.g. glaucoma)
- •Medical history with severe heart or liver disease
- •Aneurysmal vascular disease or arteriovenous malformations
- •Medical history with severe neurological disease except of headache
- •BP measured at baseline before CH attack (Systolic> 140 mmHg or / and diastolic blood pressure> 90 mm Hg)
- •Medical history with severe depression or psychosis
- •A previous history of drug abuse
- •Consumption of illegal drugs within the last 6 months
- •Medical history of nasal abnormality or dysfunction (e.g. rhinitis)
- •High disposition for larynges or apnea
- •Positive pregnancy test before treatment and no breastfeeding
- •Known hypersensitivity to ketamine
研究者
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