Headache Provocation of People Who Are Unable to Have Headache

Study Overview
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Brief Summary
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Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache. The aim of the study is to identify factors that protect against headache by studying headache after provocation in people who never have had a headache (headache resistant) versus non-resistant controls. The investigators will use isosorbide mononitrate as a pharmacological trigger of headache. The provocation is performed by investigators who are blinded to the grouping of the participants. The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.

Official Title
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Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache

Conditions
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Headache, Healthy

Intervention / Treatment
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* Drug: Isosorbide Mononitrate 60 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Headache resistant and non-resistant male participants from the Danish Blood Donor Study. Weight: 45 kg to 95 kg Exclusion Criteria: Daily consumption of any medication. Consumption of any medication less than 12 hours prior to the study day. Headache on the study day or 48 hours prior to the study day. Amnestic or clinical signs of hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg). Any severe cardiovascular disease, including cerebrovascular illness. Amnestic or clinical signs of current mental illness. Amnestic or clinical signs of current substance or drug abuse. Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Blinded case-control study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isosorbide mononitrate<br>Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day. | Drug: Isosorbide Mononitrate 60 MG<br>* 1 tablet Isosorbide Mononitrate 60 mg administrated orally.<br>* Other names: Imdur;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of headache intensity | Area under the curve of headache intensity from 0 - 5 hours post tablet administration | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of headache intensity | Area under the curve of headache intensity from 0 - 12 hours post tablet administration | 12 hours |