Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

Not Applicable

Completed

• Conditions: Migraine Without Aura
• Interventions: Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38; Drug: Vasoactive Intestinal Peptide

• Registration Number: NCT01471990
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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 available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-16
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-28
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PACAP38	Pituitary Adenylate Cyclase-Activating Polypeptide-38	-
VIP	Vasoactive Intestinal Peptide	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Headache scores	24 hours	hospital and post hospital phase
Comparison between PACAP38 and VIP induced changes in BOLD response	5 hours
Change in intracranial artery circumference before and after injection of sumatriptan	5 hours
Comparison between PACAP38 and VIP induced changes in brain structure	5 hours

Trial Locations

Locations (1)

Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen; 🇩🇰 Glostrup, Denmark