NCT02485340

The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache

The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate 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 long lasting Nitrogen Oxide (NO) donor. 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 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

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	5-ISMN (isosorbide-5-mononitrate)	5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
DRUG	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
DRUG	Placebo	5-ISMN 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: 2015-04-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-06-30
• Last updated: 2016-01-22

Locations

1 site across 1 country: Denmark