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Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers. Development of a Pragmatic Migraine Model
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be pre-treated with sumatriptan. 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 Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate cilostazol as a model, the headache must respond to specific migraine treatment with sumatriptan. Hypothesis: Cilostazol induces a migraine-like headache in healthy subjects. The induced headache can be pre-treated with a specific anti-migraine drug; sumatriptan. Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
Yes
Katrine Falkenberg
Copenhagen, Glostrup, Denmark
Start Date
May 23, 2017
Primary Completion Date
October 18, 2017
Completion Date
October 18, 2017
Last Updated
October 19, 2017
30
ACTUAL participants
Placebo
DRUG
Sumatriptan
DRUG
Lead Sponsor
Danish Headache Center
NCT06641466
NCT07018713
NCT04715685
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