NCT02066558

Brief Summary

In this study the investigators will research the hypothesis that the gas carbon monoxide induces headache and increases the blood flow velocity in the middle cerebral artery.

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 Feb 2014

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

February 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

February 17, 2014

Last Update Submit

February 11, 2015

Conditions

HeadacheMigraine

Keywords

Carbon monoxideHeadacheMigraine

Outcome Measures

Primary Outcomes (1)

  • Headache scores

    Comparison between carbon monoxide and placebo (atmospheric air)

    12 h

Secondary Outcomes (3)

  • Blood flow velocity

    0-180 min after inhalation

  • Artery circumference

    0-180 min

  • Facial blood flow

    0-180 min

Study Arms (2)

carbon monoxide

ACTIVE COMPARATOR

Inhalation of carbon monoxide up to a carboxyhemoglobin concentration of 12% and 22%.

Other: Carbon monoxide

placebo

PLACEBO COMPARATOR

Atmospheric air

Other: Placebo

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.

carbon monoxide
PlaceboOTHER
placebo

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, Denmark, 2600, Denmark

Location

MeSH Terms

Conditions

HeadacheMigraine Disorders

Interventions

Carbon Monoxide

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen Compounds

Study Officials

  • Nanna Arngrim, MD

    Danish Headache Center, Glostrup Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, medical doctor

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 19, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 12, 2015

Record last verified: 2015-02

Locations

DK(1)