Back to resultsCarbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow
Primary Purpose
Headache Disorders
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Carbon monoxide
Sponsored by
About this trial
This is an interventional other trial for Headache Disorders
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers
- Aged 18-50
- 50-100 kg
Exclusion Criteria:
- 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
- Headache within the last 24 hours before start of trial
- Hypertension
- Hypotension
- Respiratory or cardiac disease
- Smoking
- Primary relatives with current or previous migraine
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Carbon monoxide
Arm Description
Each participant receives CO inhalation
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03385174
First Posted
December 20, 2017
Last Updated
March 12, 2018
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT03385174
Brief Title
Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow
Official Title
Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
March 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbon monoxide
Arm Type
Other
Arm Description
Each participant receives CO inhalation
Intervention Type
Other
Intervention Name(s)
Carbon monoxide
Intervention Description
Carbon monoxide inhalation
Primary Outcome Measure Information:
Title
Changes in brain blood vessels diameters after a short CO inhalation
Description
To investigate changes in the circumference of intra- and extracerebral blood vessels after inhalation of carbon monoxide using magnetic resonance angiography (MRA).
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Aged 18-50
50-100 kg
Exclusion Criteria:
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
Headache within the last 24 hours before start of trial
Hypertension
Hypotension
Respiratory or cardiac disease
Smoking
Primary relatives with current or previous migraine
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
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Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow
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