Headache Provocation of People Who Are Unable to Have Headache
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|ClinicalTrials.gov Identifier: NCT04217668|
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Headache Healthy||Drug: Isosorbide Mononitrate 60 MG||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Blinded case-control study|
|Masking:||None (Open Label)|
|Masking Description:||The investigators are blinded to the case-control grouping of the participants.|
|Official Title:||Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache|
|Actual Study Start Date :||December 2, 2019|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||May 1, 2022|
Experimental: Isosorbide mononitrate
Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day.
Drug: Isosorbide Mononitrate 60 MG
1 tablet Isosorbide Mononitrate 60 mg administrated orally.
Other Name: Imdur
- Area under the curve of headache intensity [ Time Frame: 5 hours ]Area under the curve of headache intensity from 0 - 5 hours post tablet administration
- Area under the curve of headache intensity [ Time Frame: 12 hours ]Area under the curve of headache intensity from 0 - 12 hours post tablet administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217668
|Contact: Isa A Olofsson, MD||+45 38 63 20 email@example.com|
|Danish Headache Center||Recruiting|
|Glostrup, Region H, Denmark, 2600|
|Contact: Isa A Olofsson, MD +45 38 63 20 62 firstname.lastname@example.org|
|Principal Investigator: Isa A Olofsson, MD|
|Study Director:||Jes Olesen, Professor||Danish Headache Center|