Carbon Monoxide Migraine-inducing Effects in Patients Wit... | NCT03075020

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

NCT03075020

Sponsor

Danish Headache Center

Status

Completed

Last Update Posted

Dec 21, 2017Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Headache, Migraine

Interventions

Carbon monoxide
AIR

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Aug 31, 2017Actual

Completion Date

Dec 20, 2017Actual

First Submitted Date

Mar 6, 2017

First Submission Date that Met QC Criteria

Mar 6, 2017

First Posted Date

Mar 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2017

Last Update Posted Date

Dec 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active carbon monoxide	Active Comparator	Inhalation of carbon monoxide up to a carboxyhemoglobin concentration 22%	Other: Carbon monoxide
Air	Placebo Comparator		Other: AIR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carbon monoxide	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Headache scores, 12 hours	Comparison between carbon monoxide and placebo (atmospheric air)	12 hours

Secondary Outcomes

Measure	Description	Time Frame
Facial blood flow	Carbon monoxide induced changes in facial blood flow before and after inhalation.	[ Time Frame: 0-180 min ]

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Headache Center		Glostrup Municipality		2600	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002248	Carbon Monoxide
D000388	Air

Ancestor Terms

ID	Term
D017554	Carbon Compounds, Inorganic
D007287	Inorganic Chemicals
D005740	Gases
D010087	Oxides

Browse Leaves

Not provided

Browse Branches

Not provided