- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03075020
Carbon Monoxide Migraine-inducing Effects in Patients With Migraine Without Aura.
December 20, 2017 updated by: Hashmat Ghanizada, Danish Headache Center
Basic Research on Carbon Monoxide's Headache Inducing Characteristics in a Humane Experimental Headache Model
To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.
With transcranial Doppler imaging, c-scan and laser speckle the investigators will investigate changes in blood flow velocity of the middle cerebral artery (MCA), diameter of the superficial temporal artery (STA), the radial artery and facial skin perfusion.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Glostrup, Denmark, 2600
- Danish Headache Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers
- Aged 18-50
- 50-100 kg
Exclusion Criteria:
- Tension type headache more than once/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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active carbon monoxide
Inhalation of carbon monoxide up to a carboxyhemoglobin concentration 22%
|
carbon monoxide, 4.7, Purity 99.997, inhalation of carbon monoxide in a volume corresponding to carboxyhemoglobin 10 and 20%, calculated from baseline Hg and body mass
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Placebo Comparator: Air
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Room air will be administered as placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache scores, 12 hours
Time Frame: 12 hours
|
Comparison between carbon monoxide and placebo (atmospheric air)
|
12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Facial blood flow
Time Frame: [ Time Frame: 0-180 min ]
|
Carbon monoxide induced changes in facial blood flow before and after inhalation.
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[ Time Frame: 0-180 min ]
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
August 31, 2017
Study Completion (Actual)
December 20, 2017
Study Registration Dates
First Submitted
March 6, 2017
First Submitted That Met QC Criteria
March 6, 2017
First Posted (Actual)
March 9, 2017
Study Record Updates
Last Update Posted (Actual)
December 21, 2017
Last Update Submitted That Met QC Criteria
December 20, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Headache
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Gasotransmitters
- Carbon Monoxide
Other Study ID Numbers
- H-16021497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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