The Headache-inducing Effects of Levcromakalim in Patients With Cluster Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Occurrence of cluster headache attacks
研究概览
简要总结
Cluster headache is a primary headache disorder characterized by attacks of unilateral headache of short duration and severe pain intensity. There is an unmet need to understand the underlying disease mechanisms that will ultimately lead to the development of disease-specific medicines. Until now, it has been suggested that the calcitonin gene-related peptide (CGRP) plays a major role in the initiation of a cluster headache attack, possibly involving the ATP-sensitive potassium channels. The current study aims to determine whether the opening of ATP-sensitive potassium channels triggers cluster headache attacks in patients with cluster headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cluster headache patients meeting ICHD-3 criteria for episodic and chronic cluster headache of either sex. Patients were defined as having episodic cluster headache in the active phase when they had usual attacks within the last 30 days, episodic cluster headache in the remission phase when they were attack-free for at least 30 days, or chronic cluster headache when they had not had more than 30 consecutively attack-free days over the last 12 months or longer.
- •Weight between 50 and 100 kg.
- •All preventive medications, except steroid treatments or greater occipital nerve blockade within 30 days, were allowed with stable dosing.
- •Negative urinary HCG at baseline.
排除标准
- •Primary headache types except above.
- •Secondary headache disorders, according to ICHD-
- •Headache at baseline.
- •Anamnestic information or clinical signs of (at inclusion date) hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
- •Known severe or treatment-requiring cardiovascular disease including cerebrovascular disease.
- •Anamnestic or clinical evidence of mental disorder or substance abuse.
- •Anamnestic or clinical evidence of any disease considered by the investigating physician to be relevant to participation in the study.
- •Pregnant or lactating women.
研究组 & 干预措施
Levcromakalim
Intravenous infusion of levcromakalim (1 mg/20 ml). The infusion is administered at constant speed by an automatic pump, lasting 20 minutes.
干预措施: Levcromakalim (Drug)
Placebo
Intravenous infusion of placebo (sterile saline, 20 ml). The infusion is administered at constant speed by an automatic pump, lasting 20 minutes.
干预措施: Saline (Drug)
结局指标
主要结局
Occurrence of cluster headache attacks
时间窗: Change from baseline at 90 minutes after drug administration
Experimentally induced cluster headache attacks must fulfill either: 1. Headache described as mimicking the patient's usual cluster headache attack (with or without cephalic autonomic symptom). 2. Headache fulfilling criteria A and B for cluster headache according to International Classification of Headache Disorders criteria: A. Severe unilateral pain lasting 15 to 180 minutes. B. Either or both of the following: * At least 1 cephalic autonomic symptom ipsilateral to the headache. * A sense of restlessness or agitation.
次要结局
- Occurrence of headache(Change from baseline at 90 minutes after drug administration)
- Change of headache intensity scores(Change from baseline at 90 minutes after drug administration)
研究者
Messoud Ashina, MD
Professor
Danish Headache Center