Headache Provocation of People Who Are Unable to Have Headache

March 24, 2021 updated by: Isa Amalie Olofsson, Danish Headache Center

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 headache after provocation in people who never have had a headache (headache resistant) versus non-resistant controls.

The investigators will use isosorbide mononitrate as a pharmacological trigger of headache. The provocation is performed by investigators who are blinded to the grouping of the participants.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Drug: Isosorbide Mononitrate 60 MG
1 tablet Isosorbide Mononitrate 60 mg administrated orally.
Other Names:
  • Imdur

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve of headache intensity
Time Frame: 5 hours
Area under the curve of headache intensity from 0 - 5 hours post tablet administration
5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve of headache intensity
Time Frame: 12 hours
Area under the curve of headache intensity from 0 - 12 hours post tablet administration
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 2, 2019

Primary Completion (ACTUAL)

March 12, 2020

Study Completion (ACTUAL)

March 12, 2020

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

January 2, 2020

First Posted (ACTUAL)

January 3, 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

Other Study ID Numbers

  • HR002 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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