Headache DisordersNCT03385174
Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow
A study testing Carbon monoxide in people with Headache Disorders, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Studying Carbon monoxide effects on brain vessels in healthy volunteers with magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache Disorders
- What is being tested?
- Carbon monoxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 12 Mar 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Aged 18-50
- 50-100 kg
Who cannot join
- Tension type headache more than 5 dage /month
- Other primary headaches
- Daily medication except contraceptives
- Drug taken within 4 times the halflife for the specific drug except contraceptives
- Pregnant or lactating women
- Exposure to radiation within the last year
Show all 12Show fewer
- Headache within the last 24 hours before start of trial
- Hypertension
- Hypotension
- Respiratory or cardiac disease
- Smoking
- Primary relatives with current or previous migraine
Trial locations and contacts
1 site in 1 country.
About this study
Studying Carbon monoxide effects on brain vessels in healthy volunteers with magnetic resonance imaging.
Read the detailed description
In this study we will systematically investigate the headache-releasing properties of carbon monoxide as well as measure the effect of carbon monoxide on mean blood flow rate in the brain's large vessel with magnetic resonance imaging. These studies are important for understanding and further investigating the carbon monoxide's headache-releasing effect in healthy subjects.
- Conditions
- Headache Disorders
- Being tested
- Carbon monoxide
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon monoxideOther
Carbon monoxide inhalation
| Study group | Role | What they receive |
|---|---|---|
| Carbon monoxide | Other | Each participant receives CO inhalation Receives: Other: Carbon monoxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in brain blood vessels diameters after a short CO inhalation
To investigate changes in the circumference of intra- and extracerebral blood vessels after inhalation of carbon monoxide using magnetic resonance angiography (MRA).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start1 Oct 2017
- Primary completion1 Feb 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache DisordersStudies 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashmat Ghanizada, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385174
- Sponsor's protocol ID
- H-17016387
- Status last verified
- Mar 2018
- First submitted
- 20 Dec 2017
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow
- ClinicalTrials.gov ID
- NCT03385174
- Acronym / sponsor ID
- H-17016387
- Conditions
- Headache Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 28 Dec 2017 (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.
Studying Carbon monoxide effects on brain vessels in healthy volunteers with magnetic resonance imaging.
Detailed description
In this study we will systematically investigate the headache-releasing properties of carbon monoxide as well as measure the effect of carbon monoxide on mean blood flow rate in the brain's large vessel with magnetic resonance imaging. These studies are important for understanding and further investigating the carbon monoxide's headache-releasing effect in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon monoxide | Other | Other: Carbon monoxideEach participant receives CO inhalation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Aged 18-50
- 50-100 kg
Key exclusion criteria (12 listed)
- Tension type headache more than 5 dage /month
- Other primary headaches
- Daily medication except contraceptives
- Drug taken within 4 times the halflife for the specific drug except contraceptives
- Pregnant or lactating women
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 |
|---|---|---|
| Carbon monoxideCarbon monoxide inhalation | Other | Carbon monoxide |
Primary outcome
Changes in brain blood vessels diameters after a short CO inhalation
Time frame: 30 minutes
To investigate changes in the circumference of intra- and extracerebral blood vessels after inhalation of carbon monoxide using magnetic resonance angiography (MRA).
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 13 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon monoxide in people with Headache Disorders, 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 3 inclusion and 12 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 13 Mar 2018. 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?
Changes in brain blood vessels diameters after a short CO inhalation (time frame: 30 minutes). 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 13 Mar 2018.