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Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01471990
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : August 29, 2012
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner
Study Start Date : May 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Headache scores [ Time Frame: 24 hours ]
    hospital and post hospital phase

  2. Comparison between PACAP38 and VIP induced changes in BOLD response [ Time Frame: 5 hours ]
  3. Change in intracranial artery circumference before and after injection of sumatriptan [ Time Frame: 5 hours ]
  4. Comparison between PACAP38 and VIP induced changes in brain structure [ Time Frame: 5 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471990

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
Principal Investigator: Faisal Amin, M.D. Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
More Information

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
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: August 2012

Keywords provided by Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen:

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