An interventional study of Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur] and Blood sample in Headache and Healthy, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-25.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Other
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.
1,226 studies on the registry are indexed under Headache; 202 are open to participants now.
This study's enrollment of 58 is close to the median of 60 across 918 interventional studies indexed under Headache.
Browse Headache studies →Danish Headache Center is the lead sponsor of 125 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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] · Other: Blood sample
1 tablet Isosorbide Mononitrate 60 mg administrated orally.
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
Difference in RNA expression between cases and controls after headache provocation by Isosorbide Mononitrate.
Time frame: 5 hours
Metabolomic changes
Difference in metabolites between cases and controls after headache provocation by Isosorbide Mononitrate.
Time frame: 5 hours
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Danish Headache Center