The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache

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

Inclusion criteria

Healthy:

• 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.

Exclusion criteria

Healthy:

• 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).