The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache. 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
- Median headache score 0 hours after sumatriptan/placebo
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 a long lasting Nitrogen Oxide (NO) donor. 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 Isosorbide-5-mononitrate (5-ISMN), a long lasting NO-donor, 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
5-ISMN 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects of both sexes
- •age 18-70 years
- •weight 50-90 kg.
- •Females were requested to use effective contraception.
- •Migraine patients:
- •Migraine patients who meet International headache society (IHS) criteria for migraine with or without aura of both sexes
- •18-70 years
- •45-95 kg.
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, and intake of daily medication (except oral contraceptives).
研究组 & 干预措施
Sumatriptan
headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg
干预措施: 5-ISMN (isosorbide-5-mononitrate) (Drug)
Sumatriptan
headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg
干预措施: Sumatriptan (Drug)
Placebo
headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet)
干预措施: 5-ISMN (isosorbide-5-mononitrate) (Drug)
Placebo
headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet)
干预措施: Placebo (Drug)
结局指标
主要结局
Median headache score 0 hours after sumatriptan/placebo
时间窗: 0 hours
Median headache score 2 hours after sumatriptan/placebo
时间窗: 2 hours
次要结局
未报告次要终点
研究者
Emma Katrine Hansen
Medical doctor
Danish Headache Center