An interventional study of Cilostazol 200mg and SUMAtriptan 6 MG/ML in Migraine, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Treatment
To develop a pragmatic migraine model the investigators will induce headache in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan injection, 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 this model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis: Cilostazol induces a migraine-like headache in MO-patients and the induced headache responds to sumatriptan injection Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
Exclusion Criteria:
headache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan
Drug: Cilostazol 200mg · Drug: SUMAtriptan 6 MG/ML
headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb
Drug: Cilostazol 200mg · Drug: Placebo
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Also known as: Pletal
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Also known as: Imigran
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Difference in median headache score after sumatriptan/placebo
The investigators will assess the outcome measures 1 year after the beginning of the study
Time frame: 2hours
difference in AUC 0-4h post treatment
The difference in area under the curve 0-4h after treatment with sumatriptan and placebo
Time frame: 4hours
Plan to share: No
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Danish Headache Center