Carbachols Headache-inducing Effect and Changes in Cerebr... | NCT00564408

Studies
Carbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients

NCT00564408

Sponsor

Danish Headache Center

Status

Completed

Last Update Posted

Aug 3, 2009Estimated

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Headache

Interventions

Carbachol

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

Jul 2009

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

Aug 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Nov 27, 2007

First Submission Date that Met QC Criteria

Nov 27, 2007

First Posted Date

Nov 28, 2007Estimated

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

Jul 31, 2009

Last Update Posted Date

Aug 3, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to test if carbachol infusion induces headache in migraine subjects as well as intra- and extra-cerebral vasodilatation.

Detailed Description

To test if infusion of Carbachol induces headache in 12 migraine subjects as well as intra- and extra-cerebral vasodilatation in a double-blinded study

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

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Experimental		Drug: Carbachol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carbachol	Drug	3 microgram per kg bodyweight infused intravenously	I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Headache response after Carbachol infusion		1 day after infusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Migraine without aura
Weight 50-100 kg

Exclusion Criteria:

Other significant diseases
Migraine 5 days prior to experiment

Accepts Healthy Volunteers

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

Name	Affiliation	Role
Henrik Schytz, MD	Danish Headache Center	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002217	Carbachol

Ancestor Terms

ID	Term
D002794	Choline
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines

Browse Leaves

Not provided

Browse Branches

Not provided