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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Headache
• Intervention / Treatment: Drug: Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]; Other: Blood sample

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region H
    • Glostrup, Region H, Denmark, 2600
      • Danish Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Isosorbide mononitrate; 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]; 1 tablet Isosorbide Mononitrate 60 mg administrated orally.; Other: Blood sample; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Danish Headache Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2019
• Primary Completion (ACTUAL): March 12, 2020
• Study Completion (ACTUAL): March 12, 2020

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (ACTUAL): January 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Nitric Oxide Donors; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
• Other Study ID Numbers: HR003 Multiomics Provocation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No