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