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OpenTrials
Completed

NCT Number: NCT03075020

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

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

Completed

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Key information

Conditions

Headache, Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbon monoxide

Other

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

Air

Other

Room air will be administered as placebo

Primary outcomes

  1. Headache scores, 12 hours

    Time frame: 12 hours

    Comparison between carbon monoxide and placebo (atmospheric air)

Secondary outcomes

  1. Facial blood flow

    Time frame: [ Time Frame: 0-180 min ]

    Carbon monoxide induced changes in facial blood flow before and after inhalation.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

Basic Research on Carbon Monoxide's Headache Inducing Characteristics in a Humane Experimental Headache Model

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2017
Registry last updated
Dec 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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