NCT04406259进行中（未招募）4 期
Atrioventricular Block and Cluster Headache
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.
研究概览
简要总结
Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. In France, its prescription in that indication is based on compliance with the Temporary Recommendation for Use (RTU) that insists on the possible the cardiac side effects that can occur as the doses required for cluster headache are significantly higher than the doses used in cardiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient 18 years old, and older
- •patient suffering from Cluster Headache (according to the l'ICHD-3 diagnostic criterias)
- •patients affiliated to the social security
- •patient that has given his full written consent to participate in the study
- •female patients participating in the study must be using an efficient contraception for more than 1 month prior to the beginning of the study
排除标准
- •patient presenting contraindications to the use of verapamil
- •patient observing a treatment with ivabradine (Procoralan®), bétablockers, colchicine, l'esmolol, triazolam, quinidine.
- •patient under justicial protection
- •patient breastfeeding, or pregnant
- •patient suffering from a neuromuscular transmisson disease
- •patient with a pacemaker
研究组 & 干预措施
Verapamil
Other
administration of verapamil to treat cluster headache
干预措施: Verapamil (Drug)
结局指标
主要结局
Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.
时间窗: 27 months
Occurrence of the ratio of patients presenting a first degree atrioventricular block
次要结局
- Description of the different atrioventricular conduction abnormities and their incidence(27 months)
- Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram(27 months)
- Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil.(27 months)
研究者
研究点 (2)
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