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Carbon Monoxide Migraine-inducing Effects in Patients With Migraine Without Aura.

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ClinicalTrials.gov Identifier: NCT03075020
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Hashmat Ghanizada, Danish Headache Center

Brief Summary:
To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.

Condition or disease Intervention/treatment Phase
Headache, Migraine Other: Carbon monoxide Other: AIR Not Applicable

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  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Basic Research on Carbon Monoxide's Headache Inducing Characteristics in a Humane Experimental Headache Model
Actual Study Start Date : October 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active carbon monoxide
Inhalation of carbon monoxide up to a carboxyhemoglobin concentration 22%
Other: Carbon monoxide
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
Placebo Comparator: Air Other: AIR
Room air will be administered as placebo



Primary Outcome Measures :
  1. Headache scores, 12 hours [ Time Frame: 12 hours ]
    Comparison between carbon monoxide and placebo (atmospheric air)


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03075020


Locations
Denmark
Danish Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center

Responsible Party: Hashmat Ghanizada, MD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03075020     History of Changes
Other Study ID Numbers: H-16021497
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs