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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Emma Katrine Hansen
Copenhagen, Glostrup, Denmark
Median headache score 0 hours after sumatriptan/placebo
Time frame: 0 hours
Median headache score 2 hours after sumatriptan/placebo
Time frame: 2 hours
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