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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485340
• Other study ID #: H-6-2014-071
• Status: Completed
• Phase: N/A
• First received: June 4, 2015
• Last updated: January 21, 2016
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Migraine

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Denmark	Emma Katrine Hansen	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median headache score 0 hours after sumatriptan/placebo		0 hours	No
Primary	Median headache score 2 hours after sumatriptan/placebo		2 hours	No