Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

Migraine Without Aura Clinical Trial

Official title:

The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471990
• Other study ID #: H-1-2011-023
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: August 28, 2012
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine without Aura

Intervention

Drug:
• Pituitary Adenylate Cyclase-Activating Polypeptide-38
10 pmol/kg/min over 20 mins
• Vasoactive Intestinal Peptide
8 pmol/kg/min over 20 mins

Locations

Country	Name	City	State
Denmark	Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen	Glostrup

Sponsors (5)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Bispebjerg Hospital, Cool Sorption Foundation of 1988, Lundbeck Foundation, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions		Baseline, 20 minutes, 2 hours and 5 hours	No
Secondary	Headache scores	hospital and post hospital phase	24 hours	No
Secondary	Comparison between PACAP38 and VIP induced changes in BOLD response		5 hours	No
Secondary	Change in intracranial artery circumference before and after injection of sumatriptan		5 hours	No
Secondary	Comparison between PACAP38 and VIP induced changes in brain structure		5 hours	No