Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

Condition(s) targeted: Migraine Without Aura

Intervention: Pituitary Adenylate Cyclase-Activating Polypeptide-38 (Drug); Vasoactive Intestinal Peptide (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Glostrup University Hospital, Copenhagen

Official(s) and/or principal investigator(s):
Faisal Amin, M.D., Principal Investigator, Affiliation: Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen

Overall contact:
Faisal M Amin, MD, Phone: +4538633066, Email: famoam01@glo.regionh.dk

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.

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

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

Primary outcome: Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions

Secondary outcome:

Headache scores

Comparison between PACAP38 and VIP induced changes in BOLD response

Change in intracranial artery circumference before and after injection of sumatriptan

Comparison between PACAP38 and VIP induced changes in brain structure

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

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

Faisal M Amin, MD, Phone: +4538633066, Email: famoam01@glo.regionh.dk

Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen, Glostrup DK-2600, Denmark; Recruiting
Faisal M Amin, MD, Phone: +4538633066, Email: famoam01@glo.regionh.dk

Starting date: May 2011
Last updated: November 10, 2011