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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Danish Headache Center
• Treatments: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Sumatriptan

Criteria

Inclusion Criteria:

Healthy:

• healthy subjects of both sexes

• age 18-70 years

• weight 50-90 kg.

• Females were requested to use effective contraception.

Migraine patients:

• Migraine patients who meet International headache society (IHS) criteria for migraine with or without aura of both sexes

• 18-70 years

• 45-95 kg.

Exclusion Criteria:

Healthy:

• Any type of headache (except episodic tension-type headache < 1 day per week)

• Serious somatic or psychiatric disease

• Pregnancy

• Intake of daily medication (except oral contraceptives).

Migraine patients:

• Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week)

• Serious somatic or psychiatric disease

• Pregnancy, and intake of daily medication (except oral contraceptives).