Induction of Migraine Aura With Cilostazol

August 20, 2015 updated by: Christina Kruuse, Herlev Hospital

The Effect of the Selective PDE3 Inhibitor on Migraine With Aura Induction and Vascular Endothelial Function.

In a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Migraine with aura is associated to an increased risk of stroke. The mechanism behind such increased risk is not fully understood. Cilostazol induce headache and migraine in migraine patients and is used as secondary prevention of stroke. The effect on aura induction is not known. We investigate the aura inducing potential of cilostazol and associated changes in endothelial function.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital, Dept Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Migraine with aura
  • Minimum of 2 attacks/year

Exclusion Criteria:

  • Chronic tension type headache
  • Cardiac arrhythmias

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Cilostazol 200 mg single dose
Drug: Cilostazol
Single oral administration of active or placebo one week apart
Other Names:
  • Pletal
Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aura
Time Frame: 24 hours
Induction of aura reported by an aura diary for 24 hours post medication
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine
Time Frame: 24 hours
Induction of headache resembling usual migraine attacks
24 hours
Endothelial response
Time Frame: 3 hours
Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Christina Kruuse, MD PhD DMSc, Consultant Neurologist, Dept Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

August 21, 2015

Last Update Submitted That Met QC Criteria

August 20, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2013-166
  • 2013-004188-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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