PGI2 Induced Headache and Cerebral Haemodynamics in Healt... | NCT00291395

Studies
PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers

NCT00291395

Sponsor

Danish Headache Center

Status

Terminated

Last Update Posted

Oct 26, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Headache
Migraine

Interventions

PGI2

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 13, 2006

First Submission Date that Met QC Criteria

Feb 13, 2006

First Posted Date

Feb 14, 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

Oct 25, 2006

Last Update Posted Date

Oct 26, 2006Estimated

Description Module

Brief Summary

Before , during and after intravenous administration of PGI2 we score/measure headache, rCBF, blood flow in middle cerebral artery and diameter of superficial temporal artery/radial artery and correlate that to known patophysiology of headache to see if PGI2 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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
PGI2	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 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