Headache Provocation of People Who Are Unable to Have Headache

Not Applicable

Completed

• Conditions: Headache; Healthy
• Interventions: Drug: Isosorbide Mononitrate 60 MG

• Registration Number: NCT04217668
• Lead Sponsor: Danish Headache Center

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-02
• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-03
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Isosorbide mononitrate	Isosorbide Mononitrate 60 MG	Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day.

Primary Outcome Measures

Name	Time	Method
Area under the curve of headache intensity	5 hours	Area under the curve of headache intensity from 0 - 5 hours post tablet administration

Secondary Outcome Measures

Name	Time	Method
Area under the curve of headache intensity	12 hours	Area under the curve of headache intensity from 0 - 12 hours post tablet administration

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Region H, Denmark