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

• Status: Completed
• Trial end date: 2020-03-12
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Headache Center
• Treatments: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate

Criteria

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.