NCT01471990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

1.1 years

First QC Date

November 9, 2011

Last Update Submit

August 28, 2012

Conditions

Migraine Without Aura

Keywords

PACAP38MMAmigraineangiographyVIPvasodilatation

Outcome Measures

Primary Outcomes (1)

  • Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions

    Baseline, 20 minutes, 2 hours and 5 hours

Secondary Outcomes (4)

  • Headache scores

    24 hours

  • 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

Study Arms (2)

PACAP38

ACTIVE COMPARATOR
Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38

VIP

ACTIVE COMPARATOR
Drug: Vasoactive Intestinal Peptide

Interventions

Pituitary Adenylate Cyclase-Activating Polypeptide-38DRUG

10 pmol/kg/min over 20 mins

PACAP38
Vasoactive Intestinal PeptideDRUG

8 pmol/kg/min over 20 mins

VIP

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy migraine patient without aura
  • Age 18-40
  • Weight 50-100 kg
  • Fertile women must use safe contraceptives

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen

Glostrup Municipality, DK-2600, Denmark

Location

MeSH Terms

Conditions

Migraine without AuraMigraine DisordersAneurysm

Interventions

Vasoactive Intestinal Peptide

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Faisal Amin, M.D.

    Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 16, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations

DK(1)