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

NCT ID: NCT04218760

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2020-03-12

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.

Conditions

Headache; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]

Intervention Type: DRUG

1 tablet Isosorbide Mononitrate 60 mg administrated orally.

Blood sample

Intervention Type: OTHER

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.

Interventions

Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]

1 tablet Isosorbide Mononitrate 60 mg administrated orally.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Isa Amalie Olofsson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jes Olesen, Professor

Role: STUDY_DIRECTOR

Danish Headache Center

Locations

Danish Headache Center

Glostrup Municipality, Region H, Denmark

Countries

Denmark

Other Identifiers

HR003 Multiomics Provocation

Identifier Type: -

Identifier Source: org_study_id