NCT03075020

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

March 6, 2017

Last Update Submit

December 20, 2017

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (1)

  • Headache scores, 12 hours

    Comparison between carbon monoxide and placebo (atmospheric air)

    12 hours

Secondary Outcomes (1)

  • Facial blood flow

    [ Time Frame: 0-180 min ]

Study Arms (2)

Active carbon monoxide

ACTIVE COMPARATOR

Inhalation of carbon monoxide up to a carboxyhemoglobin concentration 22%

Other: Carbon monoxide

Air

PLACEBO COMPARATOR
Other: AIR

Interventions

Carbon monoxideOTHER

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

Active carbon monoxide
AIROTHER

Room air will be administered as placebo

Air

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Aged 18-50

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Carbon MonoxideAir

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen CompoundsAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 9, 2017

Study Start

October 1, 2016

Primary Completion

August 31, 2017

Study Completion

December 20, 2017

Last Updated

December 21, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)