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Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

NCT ID: NCT01471990

Last Updated: 2012-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Migraine Without Aura

Keywords

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PACAP38 MMA migraine angiography VIP vasodilatation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PACAP38

Group Type ACTIVE_COMPARATOR

Pituitary Adenylate Cyclase-Activating Polypeptide-38

Intervention Type DRUG

10 pmol/kg/min over 20 mins

VIP

Group Type ACTIVE_COMPARATOR

Vasoactive Intestinal Peptide

Intervention Type DRUG

8 pmol/kg/min over 20 mins

Interventions

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Pituitary Adenylate Cyclase-Activating Polypeptide-38

10 pmol/kg/min over 20 mins

Intervention Type DRUG

Vasoactive Intestinal Peptide

8 pmol/kg/min over 20 mins

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

Lundbeck Foundation

OTHER

Sponsor Role collaborator

Cool Sorption Foundation of 1988

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Faisal Mohammad Amin

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Faisal Amin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen

Locations

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Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-1-2011-023

Identifier Type: -

Identifier Source: org_study_id