<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02253004</url>
  </required_header>
  <id_info>
    <org_study_id>H-3-2013-166</org_study_id>
    <secondary_id>2013-004188-29</secondary_id>
    <nct_id>NCT02253004</nct_id>
  </id_info>
  <brief_title>Induction of Migraine Aura With Cilostazol</brief_title>
  <official_title>The Effect of the Selective PDE3 Inhibitor on Migraine With Aura Induction and Vascular Endothelial Function.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herlev Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a double blind placebo-controlled cross-over study the effect of cilostazol on aura&#xD;
      induction and endothelial response is tested in patient with migraine with aura.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Migraine with aura is associated to an increased risk of stroke. The mechanism behind such&#xD;
      increased risk is not fully understood. Cilostazol induce headache and migraine in migraine&#xD;
      patients and is used as secondary prevention of stroke. The effect on aura induction is not&#xD;
      known. We investigate the aura inducing potential of cilostazol and associated changes in&#xD;
      endothelial function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Aura</measure>
    <time_frame>24 hours</time_frame>
    <description>Induction of aura reported by an aura diary for 24 hours post medication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Migraine</measure>
    <time_frame>24 hours</time_frame>
    <description>Induction of headache resembling usual migraine attacks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial response</measure>
    <time_frame>3 hours</time_frame>
    <description>Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Migraine With Aura</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cilostazol 200 mg single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cilostazol</intervention_name>
    <description>Single oral administration of active or placebo one week apart</description>
    <arm_group_label>Active</arm_group_label>
    <other_name>Pletal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Migraine with aura&#xD;
&#xD;
          -  Minimum of 2 attacks/year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic tension type headache&#xD;
&#xD;
          -  Cardiac arrhythmias&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Kruuse, MD PhD DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Neurologist, Dept Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herlev Hospital, Dept Neurology</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>August 20, 2015</last_update_submitted>
  <last_update_submitted_qc>August 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev Hospital</investigator_affiliation>
    <investigator_full_name>Christina Kruuse</investigator_full_name>
    <investigator_title>Associate professor, consultant neurologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Migraine with Aura</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cilostazol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02253004
org study id: H-3-2013-166
secondary id: 2013-004188-29
nct id: NCT02253004
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Aura
time frame: 24 hours
description: Induction of aura reported by an aura diary for 24 hours post medication
measure: Migraine
time frame: 24 hours
description: Induction of headache resembling usual migraine attacks
measure: Endothelial response
time frame: 3 hours
description: Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol
arm group label: Active
arm group type: Experimental
description: Cilostazol 200 mg single dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule
intervention type: Drug
intervention name: Cilostazol
description: Single oral administration of active or placebo one week apart
arm group label: Active
other name: Pletal
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Christina Kruuse, MD PhD DMSc
role: Principal Investigator
affiliation: Consultant Neurologist, Dept Neurology
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev Hospital
investigator full name: Christina Kruuse
investigator title: Associate professor, consultant neurologist
mesh term: Migraine Disorders
mesh term: Migraine with Aura
mesh term: Cilostazol