Back to resultsHeadache Provocation of People Who Are Unable to Have Headache
Primary Purpose
Headache, Healthy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Isosorbide Mononitrate 60 MG
Sponsored by
About this trial
This is an interventional other trial for Headache
Eligibility Criteria
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.
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Isosorbide mononitrate
Arm Description
Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day.
Outcomes
Primary Outcome Measures
Area under the curve of headache intensity
Area under the curve of headache intensity from 0 - 5 hours post tablet administration
Secondary Outcome Measures
Area under the curve of headache intensity
Area under the curve of headache intensity from 0 - 12 hours post tablet administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04217668
Brief Title
Headache Provocation of People Who Are Unable to Have Headache
Official Title
Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Healthy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Blinded case-control study
Masking
None (Open Label)
Masking Description
The investigators are blinded to the case-control grouping of the participants.
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isosorbide mononitrate
Arm Type
Experimental
Arm Description
Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day.
Intervention Type
Drug
Intervention Name(s)
Isosorbide Mononitrate 60 MG
Other Intervention Name(s)
Imdur
Intervention Description
1 tablet Isosorbide Mononitrate 60 mg administrated orally.
Primary Outcome Measure Information:
Title
Area under the curve of headache intensity
Description
Area under the curve of headache intensity from 0 - 5 hours post tablet administration
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Area under the curve of headache intensity
Description
Area under the curve of headache intensity from 0 - 12 hours post tablet administration
Time Frame
12 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jes Olesen, Professor
Organizational Affiliation
Danish Headache Center
Official's Role
Study Director
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
State/Province
Region H
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Headache Provocation of People Who Are Unable to Have Headache
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