Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers. Development of a Pragmatic Migraine Model
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
- Difference in median headache score 2 hours after cilostazol
研究概览
简要总结
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be pre-treated with sumatriptan. 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 Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO).
To validate cilostazol as a model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis
Cilostazol induces a migraine-like headache in healthy subjects. The induced headache can be pre-treated with 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
- •Healthy subjects of both sexes Age 18-60 years Weight 50-95 kg. Females were requested to use effective contraception.
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).
研究组 & 干预措施
Sumatriptan
Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg
干预措施: Sumatriptan (Drug)
Placebo
Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in median headache score 2 hours after cilostazol
时间窗: 2 hours
The investigators will assess the outcome measures 1 year after the beginning of the study
Area under the headache score curve
时间窗: 12 hours
The investigators will assess the outcome measures 1 year after the beginning of the study
次要结局
- Difference in peak headache score(12 hours)
研究者
Katrine Falkenberg
Medical doctor, PhD student, principal investigator
Danish Headache Center