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

Condition(s) targeted: Migraine

Intervention: 5-ISMN (isosorbide-5-mononitrate) (Drug); Sumatriptan (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Danish Headache Center

Official(s) and/or principal investigator(s):
Emma Katrine Hansen, Doctor, Principal Investigator, Affiliation: Danish Headache Center

Overall contact:
Emma Katrine Hansen, Doctor, Phone: +45 21 15 84 08, Email: emma.katrine.hansen.02@regionh.dk

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.

Official title: The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache. Development of a Pragmatic Migraine Model

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Median headache score 0 hours after sumatriptan/placebo

Median headache score 2 hours after sumatriptan/placebo

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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).

Emma Katrine Hansen, Doctor, Phone: +45 21 15 84 08, Email: emma.katrine.hansen.02@regionh.dk

Emma Katrine Hansen, Copenhagen, Glostrup 2600, Denmark; Recruiting
Emma Katrine Hansen, Doctor, Phone: +45 21 15 84 08, Email: emma.katrine.hansen.02@regionh.dk

Starting date: April 2015
Last updated: July 1, 2015