Headache Inducing Characteristics and Possible Changes in... | NCT00374530

Studies
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of PGE2

NCT00374530

Sponsor

Danish Headache Center

Status

Completed

Last Update Posted

Aug 1, 2007Estimated

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Headache
Migraine

Interventions

PGE2

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 2007

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 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 8, 2006

First Submission Date that Met QC Criteria

Sep 8, 2006

First Posted Date

Sep 11, 2006Estimated

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, 2007

Last Update Posted Date

Aug 1, 2007Estimated

Description Module

Brief Summary

Before, during and after intravenous administration of PGE2 we score/measure headache, rCBF, blood flow in the middle cerebral artery and diameter of superficial temporal artery and correlate that to known pathophysiology of headache to see if PGE2 is involved in headache pathophysiology.

Detailed Description

Not provided

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

Name	Type	Description	Arm Group Labels	Other Names
PGE2	Drug

Measure	Description	Time Frame
Headache

Measure	Description	Time Frame
rCBF, blood flow, diameter of STA/RA, HR, BP

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Primary Headache, headache on the day of the investigation, hypertension, hypotension, pregnant/nursing, daily intake of medication (except oral contraceptives), Cardiovascular or CNS disease, drug/alcohol abuse, psychiatric disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Troels Wienecke, MD	Danish Headache Center	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache
D008881	Migraine Disorders

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
D015232	Dinoprostone

Ancestor Terms

ID	Term
D011458	Prostaglandins E
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated

Browse Leaves

Not provided

Browse Branches

Not provided