Headache Provocation of People Who Are Unable to Have Headache
NCT ID: NCT04217668
Last Updated: 2021-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2019-12-02
2020-03-12
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Isosorbide mononitrate
Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day.
Isosorbide Mononitrate 60 MG
1 tablet Isosorbide Mononitrate 60 mg administrated orally.
Interventions
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Isosorbide Mononitrate 60 MG
1 tablet Isosorbide Mononitrate 60 mg administrated orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight: 45 kg to 95 kg
Exclusion Criteria
* 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.
18 Years
70 Years
MALE
No
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Isa Amalie Olofsson
Medical Doctor, PhD student
Principal Investigators
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Jes Olesen, Professor
Role: STUDY_DIRECTOR
Danish Headache Center
Locations
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Danish Headache Center
Glostrup Municipality, Region H, Denmark
Countries
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Other Identifiers
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HR002 Provocation
Identifier Type: -
Identifier Source: org_study_id
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