Multiomics After Headache Provocation of People Who Are Unable to Have Headache

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Danish Headache Center
Updated on 19 February 2024
headache
isosorbide mononitrate
imdur

Summary

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.

Details
Condition Headache, Pain, Pain, Healthy
Age 18-70 years
Treatment Blood sample, Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]
Clinical Study IdentifierNCT04218760
SponsorDanish Headache Center
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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