CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Differences in occurence of cluster headache attacks on CGRP day compared to placebo day in all three groups
研究概览
简要总结
It has previously been shown that nitroglycerine induces cluster headache attacks in episodic cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore, plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be significantly higher during, but not before and after, an attack.
The attack appears around 20-40 min after nitroglycerine infusion with vasodilatation. During this latency period preceding the attack, no increase in CGRP plasma concentrations is seen. CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as well as monoclonal antibodies against CGRP are effective in migraine treatment.
Based on the above the investigators hypothesize the following:
- Provoking ECH patients in bout with CGRP triggers cluster headache attacks
- Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks
- Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks more often than in ECH patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Fulfillment of IHS criteria for cluster headache either chronic or episodic
- •Patients in bouts 1-32 attacks per week
- •Patients in remission minimum of 1 month remission time
- •fertile women must use safe contraception
排除标准
- •All other primary types of headache
- •headache 8 hours or less before study day begins
- •pregnant or lactating women
- •any history or clinical sigs of hyper/hypotension, heart disease, mental disorder, substance abuse, or other illness deemed relevant by the medical doctor assessing the patient
研究组 & 干预措施
Active
1.5µg/min IV calcitonin-gene related peptide for 20 minutes
干预措施: Calcitonin-Gene Related Peptide (Drug)
Placebo
IV placebo for 20 minutes
干预措施: Placebo (Drug)
结局指标
主要结局
Differences in occurence of cluster headache attacks on CGRP day compared to placebo day in all three groups
时间窗: 90 min after administration of study drug
Occurence of experimentally induced cluster headache attack yes/no
AUC headache on CGRP day compared to placebo day in all three groups
时间窗: 90 min after administration of study drug
Using 90 min headache questionnaire
Time to maximum headache score on CGRP day compared to placebo day in all three
时间窗: 90 min after administration of study drug
Using 90 min headache questionnaire
次要结局
未报告次要终点
研究者
Song Guo
Medical doctor, Ph.d. student
Danish Headache Center