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

NCT ID: NCT03075020

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Headache, Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active carbon monoxide

Inhalation of carbon monoxide up to a carboxyhemoglobin concentration 22%

Group Type ACTIVE_COMPARATOR

Carbon monoxide

Intervention Type 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

Group Type PLACEBO_COMPARATOR

AIR

Intervention Type OTHER

Room air will be administered as placebo

Interventions

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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

Intervention Type OTHER

AIR

Room air will be administered as placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Hashmat Ghanizada

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danish Headache Center

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-16021497

Identifier Type: -

Identifier Source: org_study_id