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Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

This study has been completed.
Sponsor:
Collaborators:
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Lundbeck Foundation
Cool Sorption Foundation of 1988
Information provided by (Responsible Party):
Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01471990
First received: November 9, 2011
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Migraine Without Aura
 Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
Drug: Vasoactive Intestinal Peptide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions [ Time Frame: Baseline, 20 minutes, 2 hours and 5 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Headache scores [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    hospital and post hospital phase

  • Comparison between PACAP38 and VIP induced changes in BOLD response [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • Change in intracranial artery circumference before and after injection of sumatriptan [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • Comparison between PACAP38 and VIP induced changes in brain structure [ Time Frame: 5 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PACAP38 Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
10 pmol/kg/min over 20 mins
Active Comparator: VIP Drug: Vasoactive Intestinal Peptide
8 pmol/kg/min over 20 mins

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471990

Locations
Denmark
Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
Glostrup, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Lundbeck Foundation
Cool Sorption Foundation of 1988
Investigators
Principal Investigator: Faisal Amin, M.D. Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
  More Information

No publications provided

Responsible Party: Faisal Mohammad Amin, medical doctor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01471990     History of Changes
Other Study ID Numbers: H-1-2011-023
Study First Received: November 9, 2011
Last Updated: August 28, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Glostrup University Hospital, Copenhagen:
PACAP38
MMA
migraine
 angiography
VIP
vasodilatation

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vasoactive Intestinal Peptide
Pituitary Adenylate Cyclase-Activating Polypeptide
Vasodilator Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013