NCT03385174

Brief Summary

Studying Carbon monoxide effects on brain vessels in healthy volunteers with magnetic resonance imaging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

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, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

December 20, 2017

Last Update Submit

March 12, 2018

Conditions

Headache Disorders

Outcome Measures

Primary Outcomes (1)

  • Changes in brain blood vessels diameters after a short CO inhalation

    To investigate changes in the circumference of intra- and extracerebral blood vessels after inhalation of carbon monoxide using magnetic resonance angiography (MRA).

    30 minutes

Study Arms (1)

Carbon monoxide

OTHER

Each participant receives CO inhalation

Other: Carbon monoxide

Interventions

Carbon monoxideOTHER

Carbon monoxide inhalation

Carbon monoxide

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 5 dage /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

Headache Disorders

Interventions

Carbon Monoxide

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 28, 2017

Study Start

October 1, 2017

Primary Completion

February 1, 2018

Study Completion

March 12, 2018

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

DK(1)