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OpenTrials
Completed

NCT Number: NCT04217668

Headache Provocation 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.

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Key information

Conditions

Headache Healthy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, Region H, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isosorbide Mononitrate 60 MG

Drug

1 tablet Isosorbide Mononitrate 60 mg administrated orally.

Other names: Imdur

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 3, 2020
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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