Multiomics After Headache Provocation of People Who Are Unable to Have Headache
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|ClinicalTrials.gov Identifier: NCT04218760|
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : January 9, 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 multiomics in people who never have had a headache (headache resistant) versus non-resistant controls.
The investigators will measure multiomic changes (transcriptomics and metabolomics) after headache provocation with isosorbide mononitrate. 3 blood samples, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate.
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 Extended Release Oral Tablet [Imdur] Other: Blood sample||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Case-control study.|
|Masking:||None (Open Label)|
|Official Title:||Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache|
|Actual Study Start Date :||October 10, 2019|
|Estimated Primary Completion Date :||May 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 and have 3 sets of blood samples drown.
Drug: Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]
1 tablet Isosorbide Mononitrate 60 mg administrated orally.
Other: Blood sample
3 blood samples from a periferal vein, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate.
- Transcriptomic changes [ Time Frame: 5 hours ]Difference in RNA expression between cases and controls after headache provocation by Isosorbide Mononitrate.
- Metabolomic changes [ Time Frame: 5 hours ]Difference in metabolites between cases and controls after headache provocation by Isosorbide Mononitrate.
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): NCT04218760
|Contact: Isa A Olofsson, MD||+45 38 63 20 firstname.lastname@example.org|
|Danish Headache Center||Recruiting|
|Glostrup, Region H, Denmark, 2600|
|Contact: Isa A Olofsson, MD +45 38 63 20 62 email@example.com|
|Principal Investigator: Isa A Olofsson, MD|
|Study Director:||Jes Olesen, Professor||Danish Headache Center|