Headache Provocation of People Who Are Unable to Have Headache

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04217668
• Other study ID #: HR002 Provocation
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: March 12, 2020

Study information

• Verified date: March 2021
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Healthy

Intervention

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

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup	Region H

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of headache intensity	Area under the curve of headache intensity from 0 - 5 hours post tablet administration	5 hours
Secondary	Area under the curve of headache intensity	Area under the curve of headache intensity from 0 - 12 hours post tablet administration	12 hours