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

Primary Purpose

Headache, Migraine

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Carbon monoxide
AIR
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Headache, Migraine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Danish Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active carbon monoxide

Air

Arm Description

Inhalation of carbon monoxide up to a carboxyhemoglobin concentration 22%

Outcomes

Primary Outcome Measures

Headache scores, 12 hours
Comparison between carbon monoxide and placebo (atmospheric air)

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2017
Last Updated
December 20, 2017
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT03075020
Brief Title
Carbon Monoxide Migraine-inducing Effects in Patients With Migraine Without Aura.
Official Title
Basic Research on Carbon Monoxide's Headache Inducing Characteristics in a Humane Experimental Headache Model
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active carbon monoxide
Arm Type
Active Comparator
Arm Description
Inhalation of carbon monoxide up to a carboxyhemoglobin concentration 22%
Arm Title
Air
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Carbon monoxide
Intervention Description
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
Intervention Name(s)
AIR
Intervention Description
Room air will be administered as placebo
Primary Outcome Measure Information:
Title
Headache scores, 12 hours
Description
Comparison between carbon monoxide and placebo (atmospheric air)
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Facial blood flow
Description
Carbon monoxide induced changes in facial blood flow before and after inhalation.
Time Frame
[ Time Frame: 0-180 min ]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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