The Effect of PACAP-38 Infusion in Inducing Headache in Patients With Cluster Headache
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Headache
研究概览
简要总结
A randomized, double-blinded, two-way crossover study investigating the headache inducing capabilities of PACAP-38 in patients with cluster headache. Forty-five patients (15 episodic patients in cluster, 15, episodic patients in remission and 15 chronic cluster headache patients) are expected to participate. Each patients will on two separate study days in a randomized way receive an infusion of PACAP-38 and VIP over 20 minutes followed by an observation period of 70 minutes. Blood samples for investigation of VIP, PACAP38; CGRP, NSE, Histamine and Tryptase will be drawn at fixed time-points during experiment.
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
- Single (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
- •Episodic or chronic cluster headache according to international classification of headache disorders
- •Age 18-65 years
- •Weight 50-100 kg
- •If women of childbearing potential, then must use safe contraceptives
排除标准
- •Episodic tension-type headache > 15 days per month
- •Other primary headache disorders, except tension-type headache < 5 days per month
- •Episodic cluster headache patients outside cluster must be completely headache free a minimum of 8 hours prior to experiment
- •Episodic cluster headache patients in cluster and chronic cluster headache patients must be completely headache free a minimum of 4 hours prior to experiment
- •Current or recent use (30 days) of injected or oral corticosteroids
- •Pregnant or lactating women
- •A history or clinical signs of hypertension (BP > 150mmHg systolic / 100mmHg diastolic)
- •A history or clinical signs of hypotension (BP <90 mmHg systolic / 50mmHg diastolic)
- •A history of cardiovascular or cerebrovascular disease
- •A history of psychiatric disease or substance abuse
- •A medical history or clinical signs of disease that according to investigator would preclude participation in the study
研究组 & 干预措施
PACAP-38 infusion
According to main hypothesis PACAP-38 is expected to induce headache. PACAP-38 causes marked vasodilation visible to investigator. PACAP38 (10 pmol/kg/min) is infused over 20 minutes, patients are observed before (15 minutes), during and after (70 minutes) infusion. Blood samples are drawn at fixed time-points.
干预措施: Evaluation of headache inducing capabilities of PACAP38 (Other)
VIP infusion
According to main hypothesis VIP is not expected to induce headache. VIP also causes marked vasodilation visible to investigator, which is why VIP is chosen as an active comparator. VIP (10 pmol/kg/min) is infused over 20 minutes. VIP is infused over 20 minutes, patients are observed before (15 minutes), during and after (70 minutes) infusion. Blood samples are drawn at fixed time-points.
干预措施: Evaluation of headache inducing capabilities of PACAP38 (Other)
结局指标
主要结局
Headache
时间窗: 90 minutes
Difference in incidence of headache within 90 minutes of infusion between PACAP-38 infusion and VIP infusion
Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE
时间窗: 90 minutes
Changes in plasma/serum concentrations of the following markers after infusion of PACAP-38 and VIP: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE
Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE after infusion
时间窗: 90 minutes
Difference in plasma/serum concentrations of the following markers after infusion of PACAP-38 and VIP: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE between patients with induced cluster headache and patients without headache
Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline
时间窗: 90 minutes
Difference in plasma/serum concentrations of the following markers at baseline: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE between patients with episodic cluster headache in remission, episodic cluster headache in cluster, and chronic cluster headache
Headache intensity
时间窗: 90 minutes
Difference in AUD for headache intensity scores (0-90 minutes)
Time to headache peak
时间窗: 90 minutes
Difference in time to peak headache between PACAP-38 day and VIP day
次要结局
- Change in mean arterial blood pressure(90 minutes)
- Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE(Baseline)
研究者
Agneta Snoer
MD, PhD Student, Investigator
Danish Headache Center