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

NCT04218760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-03-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Danish Headache Center

    lead OTHER

Principal Investigators

  • Jes Olesen, Professor · Danish Headache Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2020-03-12
Completion
2020-03-12

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04218760 on ClinicalTrials.gov