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

Headache, Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075020
• Other study ID #: H-16021497
• Status: Completed
• Phase: N/A
• First received: March 6, 2017
• Last updated: December 20, 2017
• Start date: October 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: December 2017
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 20, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders
• Migraine without Aura

Intervention

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
• AIR
Room air will be administered as placebo

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache scores, 12 hours	Comparison between carbon monoxide and placebo (atmospheric air)	12 hours
Secondary	Facial blood flow	Carbon monoxide induced changes in facial blood flow before and after inhalation.	[ Time Frame: 0-180 min ]