NCT02486276

The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache. Development of a Pragmatic Migraine Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Detailed description

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 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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Cilostazol	Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
DRUG	Sumatriptan	Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
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

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-07-01
• Last updated: 2017-05-09

Locations

1 site across 1 country: Denmark