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

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Drug: 5-ISMN (isosorbide-5-mononitrate); Drug: Placebo; Drug: Sumatriptan

• Registration Number: NCT02485340
• Lead Sponsor: Danish Headache Center

Brief 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

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-30
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	5-ISMN (isosorbide-5-mononitrate)	headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet)
Sumatriptan	5-ISMN (isosorbide-5-mononitrate)	headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg
Placebo	Placebo	headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet)
Sumatriptan	Sumatriptan	headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg

Primary Outcome Measures

Name	Time	Method
Median headache score 0 hours after sumatriptan/placebo	0 hours
Median headache score 2 hours after sumatriptan/placebo	2 hours

Trial Locations

Locations (1)

Emma Katrine Hansen; 🇩🇰 Copenhagen, Glostrup, Denmark