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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
Sponsor:
Information provided by (Responsible Party):
Isa Amalie Olofsson, Danish Headache Center

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Case-control study.
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Transcriptomic changes [ Time Frame: 5 hours ]
    Difference in RNA expression between cases and controls after headache provocation by Isosorbide Mononitrate.

  2. Metabolomic changes [ Time Frame: 5 hours ]
    Difference in metabolites between cases and controls after headache provocation by Isosorbide Mononitrate.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Isa A Olofsson, MD +45 38 63 20 62 isa.amalie.olofsson@regionh.dk

Locations
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Denmark
Danish Headache Center Recruiting
Glostrup, Region H, Denmark, 2600
Contact: Isa A Olofsson, MD    +45 38 63 20 62    isa.amalie.olofsson@regionh.dk   
Principal Investigator: Isa A Olofsson, MD         
Sponsors and Collaborators
Danish Headache Center
Investigators
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Study Director: Jes Olesen, Professor Danish Headache Center

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Responsible Party: Isa Amalie Olofsson, Principal Investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT04218760    
Other Study ID Numbers: HR003 Multiomics Provocation
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action