Migraine Clinical Trial
Official title:
The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache. Development of a Pragmatic Migraine Model
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
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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