HeadacheNCT04218760
Multiomics After Headache Provocation of People Who Are Unable to Have Headache
A study testing Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur] and Blood sample in people with Headache and Healthy, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- What is being tested?
- Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur] and Blood sample
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Oct 2019to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
- Weight: 45 kg to 95 kg
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
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.
Read more
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.
- Being tested
- Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur], Blood sample
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]Drug
1 tablet Isosorbide Mononitrate 60 mg administrated orally.
Blood sampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Isosorbide mononitrate | Experimental | Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day and have 3 sets of blood samples drown. Receives: Drug: Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]; Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptomic changes
Difference in RNA expression between cases and controls after headache provocation by Isosorbide Mononitrate.
Measured: 5 hours
Metabolomic changes
Difference in metabolites between cases and controls after headache provocation by Isosorbide Mononitrate.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start10 Oct 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case-control study.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isa Amalie Olofsson, Danish Headache Center
- Investigators
- Jes Olesen, Professor, Study director, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218760
- Sponsor's protocol ID
- HR003 Multiomics Provocation
- Status last verified
- Mar 2021
- First submitted
- 3 Jan 2020
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
- ClinicalTrials.gov ID
- NCT04218760
- Acronym / sponsor ID
- HR003 Multiomics Provocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case-control study.
| Arm | Type | Receives |
|---|---|---|
| Isosorbide mononitrate | Experimental | Drug: Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur], Other: Blood sampleCases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day and have 3 sets of blood samples drown. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
- Weight: 45 kg to 95 kg
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]1 tablet Isosorbide Mononitrate 60 mg administrated orally. | Drug | Isosorbide mononitrate |
| Blood sample3 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. | Other | Isosorbide mononitrate |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jes Olesen, Professor study director
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur] and Blood sample in people with Headache and Healthy, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptomic changes (time frame: 5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.