Effect of PACAP38/VIP on Migraineurs Measured by Magnetic... | NCT01471990

Studies
Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

NCT01471990

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Aug 29, 2012Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Migraine Without Aura

Interventions

Pituitary Adenylate Cyclase-Activating Polypeptide-38
Vasoactive Intestinal Peptide

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

Aug 2012

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

May 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Nov 9, 2011

First Submission Date that Met QC Criteria

Nov 10, 2011

First Posted Date

Nov 16, 2011Estimated

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

Aug 28, 2012

Last Update Posted Date

Aug 29, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Faisal Mohammad Amin, medical doctor, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Name	Class
Bispebjerg Hospital	OTHER
University Hospital, Gentofte, Copenhagen	OTHER
Lundbeck Foundation	OTHER
Cool Sorption Foundation of 1988

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

The purpose of this study is to examine and compare the effect of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on intracranial arteries and neuronal activity in patients with migraine without aura using a high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and functional MRI (fMRI).

MRA will be used to detect changes in intracranial artery circumferences before and after PACAP38 and VIP.

fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal (BOLD-signal).

PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine specific drug sumatriptan will be given to relieve pain and the effect will also be registered using MRA and fMRI.

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PACAP38	Active Comparator		Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
VIP	Active Comparator		Drug: Vasoactive Intestinal Peptide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pituitary Adenylate Cyclase-Activating Polypeptide-38	Drug	10 pmol/kg/min over 20 mins	PACAP38

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions		Baseline, 20 minutes, 2 hours and 5 hours

Secondary Outcomes

Measure	Description	Time Frame
Headache scores	hospital and post hospital phase	24 hours
Comparison between PACAP38 and VIP induced changes in BOLD response		5 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy migraine patient without aura
Age 18-40
Weight 50-100 kg
Fertile women must use safe contraceptives

Exclusion Criteria:

Tension type headache more than 5 days per month
Other primary headaches
Daily use of medication except contraceptives
Drug taken within 4 times the half life for the specific drug except contraceptives
Pregnant or lactating women
Exposure to radiation within the last year
Hypotension or hypertension
Cardiovascular or cerebrovascular disease
Mental illness or substance abuse
Other significant conditions determined by the examining doctor
Contraindications to MRI scan
Headache within the last 48 hours before start of trial

Accepts Healthy Volunteers

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
Faisal Amin, M.D.	Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen		Glostrup Municipality		DK-2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020326	Migraine without Aura
D008881	Migraine Disorders
D000783	Aneurysm

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
D014660	Vasoactive Intestinal Peptide

Ancestor Terms

ID	Term
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided