EUCTR2018-003382-34-DK进行中（未招募）1 期
Prophylactic effects of psilocybin on chronic cluster headache: an open-label clinical trial and neuroimaging study.
euroPharm0 个研究点目标入组 20 人开始时间: 2018年8月30日最近更新:
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
入选标准
- •Age between 18 and 65
- •A diagnosis of chronic cluster headache according to IHCD-III.
- •Ability to separate cluster headache attacks from other types of headache.
- •A history of at least 4 attacks/week in the last 4 weeks before inclusion
- •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
- •A history of using a serotonergic hallucinogen for CH.
- •Participation in any clinical trials within 30 days preceding study enrollment.
- •Use of other prophylactic CH medication within the last two weeks.
- •Current use of drugs suspected to interfere with treatment (e.g. antipsychotic medication).
- •Current use of drugs suspected to be hazardous in combination with psilocybin.
- •Presence of other trigeminal autonomic cephalalgias.
- •Known hypersensitivity/allergy to multiple drugs (including psilocybin).
- •A history or presence of any medical and psychiatric condition that might render patient unsuitable for participation.
- •Present or previous manic or psychotic disorder or critical psychiatric disorder.
- •Current drug or alcohol abuse.
- •MRI Contraindications.
- •Pregnancy or breastfeeding .
- •Not using safe contraception (if fertile woman).
- •Stroke (<1 year from inclusion).
- •Myocardial infarction (<1 year from inclusion).
- •Hypertension (> 140/90 mmHg at inclusion).
- •Clinically significant arrhythmia (<1 year from inclusion).
研究者
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