The Effect of Sumatriptan and Placebo Injection on Cilostazol 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
- difference in AUC 0-4h post treatment
研究概览
简要总结
To develop a pragmatic migraine model the investigators will induce headache in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan injection, 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 this model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis
Cilostazol induces a migraine-like headache in MO-patients and the induced headache responds to sumatriptan injection 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine patients who meet IHS criteria for migraine with or without aura of both sexes
- •18-70 years
- •45-95 kg.
排除标准
- •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 Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan
干预措施: Cilostazol 200mg (Drug)
Sumatriptan
headache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan
干预措施: SUMAtriptan 6 MG/ML (Drug)
Placebo
headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb
干预措施: Cilostazol 200mg (Drug)
Placebo
headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb
干预措施: Placebo (Drug)
结局指标
主要结局
difference in AUC 0-4h post treatment
时间窗: 4hours
The difference in area under the curve 0-4h after treatment with sumatriptan and placebo
Difference in median headache score after sumatriptan/placebo
时间窗: 2hours
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