Headache Provocation of People Who Are Unable to Have Headache

NCT04217668 | Completed

• 1 other identifier: HR002 Provocation
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the curve of headache intensity

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

  5 hours

Secondary Outcomes (1)

• Area under the curve of headache intensity

  12 hours

Study Arms (1)

Isosorbide mononitrate

EXPERIMENTAL

Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day.

Drug: Isosorbide Mononitrate 60 MG

Interventions

Isosorbide Mononitrate 60 MG DRUG

1 tablet Isosorbide Mononitrate 60 mg administrated orally.

Also known as: Imdur

Isosorbide mononitrate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
• Weight: 45 kg to 95 kg

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Region H, 2600, Denmark

Location

MeSH Terms

Conditions

Headache

Interventions

isosorbide-5-mononitrate

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jes Olesen, Professor

  Danish Headache Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The investigators are blinded to the case-control grouping of the participants.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD student

Model Details: Blinded case-control study

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 3, 2020
• Study Start: December 2, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: March 25, 2021

Record last verified: 2021-03

Locations

DK (1)