PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypep... | NCT00380263

Studies
PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

NCT00380263

Sponsor

Danish Headache Center

Status

Completed

Last Update Posted

May 30, 2008Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Migraine Without Aura

Interventions

PACAP38

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

May 2008

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

Nov 2006

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Sep 21, 2006

First Submission Date that Met QC Criteria

Sep 21, 2006

First Posted Date

Sep 25, 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

May 29, 2008

Last Update Posted Date

May 30, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To investigate headache score and accompanying symptoms during and after infusion of PACAP38 i migraine patients

Detailed Description

To investigate headache score and accompanying symptoms during and after infusion of PACAP38

Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Name	Type	Description	Arm Group Labels	Other Names
PACAP38	Drug	10 pmol/kg/min given one time

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy migraine patient without aura
Aged 18-50
50-100 kg
Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

Exclusion Criteria:

Tension type headache more than five times/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 48 hours before start of trial
Hypertension
Hypotension
Respiratory or cardiac disease

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
Dansih Headache Center		Glostrup Municipality		2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020326	Migraine without Aura

Ancestor Terms

ID	Term
D008881	Migraine Disorders
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D051219	Pituitary Adenylate Cyclase-Activating Polypeptide

Ancestor Terms

ID	Term
D009414	Nerve Growth Factors
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided