The Headache Inducing Effects of Cilostazol on Migraine Patients

June 5, 2014 updated by: Song Guo, Danish Headache Center
We will use Cilostazol as a tool to investigate its headache inducing effects in migraine patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

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
    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Danish Headache Center & Department of 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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with migraine without aura according to the IHS criteria from 2004.
  • Healthy besides migraine

Exclusion Criteria:

  • Tension-type headache more than 3 days per month
  • Other types of primary headaches
  • Pregnancy
  • History of vascular diseases or psychiatric diseases.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cilostazol
Capsule of Cilostazol 200 mg are taken orally on each study day
Drug: Cilostazol
Other Names:
  • Pletal
Placebo Comparator: Placebo
A capsule of placebo containing starch are taken orally on each study day.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidens of headache or migraine after adminstration of Cilostazol in migraine patients compared to placebo.
Time Frame: Outcome measure will be done within 3 month. Final data will be presented within 6 months
Rectruitment of 14 patients will be done during April and May. Experiments will be carried out in May and June. Each experiment day takes 1½ hour. Data analysis will be done in June and July. Final data will be presented within 6 months.
Outcome measure will be done within 3 month. Final data will be presented within 6 months

Collaborators and Investigators

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

Sponsor

Danish Headache Center

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

April 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 20, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (Estimate)

April 29, 2013

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2013-033

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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