The Effect of Sumatriptan and Placebo on CGRP Induced Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUC after infusion
研究概览
简要总结
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with aCalcitonine Gene Related Peptide (CGRP). If the headache responds to sumatriptan, the model can be used to test new drug candidates.
详细描述
There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Calcitonine Gene Related Peptide (CGRP) induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis
CGRP induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.
Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Any type of headache (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).
- •Migraine patients:
- •Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives) Triptan non-responders
研究组 & 干预措施
Sumatriptan
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment
干预措施: Calcitonin Gene Related Peptide (Drug)
Sumatriptan
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment
干预措施: Sumatriptan 50 mg (Drug)
Placebo
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment
干预措施: Calcitonin Gene Related Peptide (Drug)
Placebo
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
AUC after infusion
时间窗: 1 year
The investigators will assess the outcome measures 1 year after the beginning of the study
次要结局
未报告次要终点
研究者
Katrine Falkenberg
Medical doctor
Danish Headache Center