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Headache Provocation of People Who Are Unable to Have Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217668
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 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 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

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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.
Primary Purpose: Other
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

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.
Drug: Isosorbide Mononitrate 60 MG
1 tablet Isosorbide Mononitrate 60 mg administrated orally.
Other Name: Imdur




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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): NCT04217668


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, Medical Doctor, PhD student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT04217668    
Other Study ID Numbers: HR002 Provocation
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 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