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

Not Applicable

Completed

• Conditions: Headache; Healthy
• Interventions: Drug: Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]; Other: Blood sample

• Registration Number: NCT04218760
• Lead Sponsor: Danish Headache Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Isosorbide mononitrate	Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]	Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day and have 3 sets of blood samples drown.
Isosorbide mononitrate	Blood sample	Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day and have 3 sets of blood samples drown.

Primary Outcome Measures

Name	Time	Method
Transcriptomic changes	5 hours	Difference in RNA expression between cases and controls after headache provocation by Isosorbide Mononitrate.
Metabolomic changes	5 hours	Difference in metabolites between cases and controls after headache provocation by Isosorbide Mononitrate.

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Region H, Denmark