<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/NCT03228355</url>
  </required_header>
  <id_info>
    <org_study_id>Levcromakalim</org_study_id>
    <nct_id>NCT03228355</nct_id>
  </id_info>
  <brief_title>Headache Inducing Effect of Cromakalim in Migraine Patients</brief_title>
  <official_title>The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danish Headache Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danish Headache Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 24, 2017</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebral hemodynamic</measure>
    <time_frame>Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline</time_frame>
    <description>Change on Media cerebri arterie.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Headache</measure>
    <time_frame>Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline</time_frame>
    <description>Occurrence of headache.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Migraine attack</measure>
    <time_frame>Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline</time_frame>
    <description>Occurrence</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Headache, Migraine</condition>
  <arm_group>
    <arm_group_label>Levcromakalim</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levcromakalim</intervention_name>
    <description>To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients</description>
    <arm_group_label>Levcromakalim</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.</description>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Migraine patients of both sexes.&#xD;
&#xD;
          -  18-60 years.&#xD;
&#xD;
          -  50-90 kg.&#xD;
&#xD;
          -  Women of childbearing potential must use adequate contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Headache less than 48 hours before the tests start&#xD;
&#xD;
          -  Daily consumption of drugs of any kind other than oral contraceptives&#xD;
&#xD;
          -  Pregnant or nursing women.&#xD;
&#xD;
          -  Cardiovascular disease of any kind, including cerebrovascular diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Messoud Ashina, Professor</last_name>
    <role>Study Director</role>
    <affiliation>DHC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Danish headache center</name>
      <address>
        <city>Copenhagen</city>
        <state>Glostrup</state>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 8, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>June 18, 2018</last_update_submitted>
  <last_update_submitted_qc>June 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danish Headache Center</investigator_affiliation>
    <investigator_full_name>Mohammad Al-Mahdi Al-Karagholi</investigator_full_name>
    <investigator_title>MD, PhD student</investigator_title>
  </responsible_party>
  <keyword>Levcromakalim</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cromakalim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03228355
org study id: Levcromakalim
nct id: NCT03228355
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cerebral hemodynamic
time frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
description: Change on Media cerebri arterie.
measure: Headache
time frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
description: Occurrence of headache.
measure: Migraine attack
time frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
description: Occurrence
arm group label: Levcromakalim
arm group type: Active Comparator
arm group label: Saline
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Levcromakalim
description: To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients
arm group label: Levcromakalim
intervention type: Drug
intervention name: Saline
description: To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.
arm group label: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Messoud Ashina, Professor
role: Study Director
affiliation: DHC
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Danish Headache Center
investigator full name: Mohammad Al-Mahdi Al-Karagholi
investigator title: MD, PhD student
mesh term: Migraine Disorders
mesh term: Headache
mesh term: Cromakalim
sharing ipd: Undecided