Multiomics After 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 multiomics in people who never have had a headache (headache resistant) versus non-resistant controls. The investigators will measure multiomic changes (transcriptomics and metabolomics) after headache provocation with isosorbide mononitrate. 3 blood samples, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate. 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 Extended Release Oral Tablet [Imdur]
* Other: Blood sample


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: 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 and have 3 sets of blood samples drown. | Drug: Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]<br>* 1 tablet Isosorbide Mononitrate 60 mg administrated orally.<br>Other: Blood sample<br>* 3 blood samples from a periferal vein, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptomic changes | Difference in RNA expression between cases and controls after headache provocation by Isosorbide Mononitrate. | 5 hours | 
| Metabolomic changes | Difference in metabolites between cases and controls after headache provocation by Isosorbide Mononitrate. | 5 hours |