<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/NCT02185703</url>
  </required_header>
  <id_info>
    <org_study_id>PM004</org_study_id>
    <nct_id>NCT02185703</nct_id>
  </id_info>
  <brief_title>Chordate System S020 Acute Migraine Clinical Investigation</brief_title>
  <acronym>Amici</acronym>
  <official_title>A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Performance and Safety of the Chordate System When Used in the Treatment of Acute Migraine Attacks of Moderate to Severe Intensity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chordate Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chordate Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the study is to evaluate the impact of treatment with the Chordate System&#xD;
      S020 (medical device) on acute migraine headache pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One single migraine attack will be treated either with the Chordate System S020 or with&#xD;
      Chordate System in placebo mode.&#xD;
&#xD;
      After a screening visit, up to 3 months before treatment, eligible subjects will be asked to&#xD;
      return to the center at the onset of their next moderate to severe migraine attack. Subjects&#xD;
      will be re-checked for eligibility, randomized and treated at the center (treatment visit).&#xD;
      The subjects will record their response over the next 48 hours using a diary card. A&#xD;
      follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects&#xD;
      will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to&#xD;
      discuss their health including new or ongoing AEs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Too slow recruitment rate&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Headache relief</measure>
    <time_frame>2 hours after treatment initiation</time_frame>
    <description>Percentage of subjects with a decrease in migraine headache pain from severe or moderate prior treatment to mild or none at 2 hours after treatment initiation with no use of rescue medication during this time period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain-free rate</measure>
    <time_frame>2 hours after treatment initiation</time_frame>
    <description>Percentage of subjects pain-free (pain intensity rated 'No pain') at 2 hours after treatment initiation with no use of rescue medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of recurrence</measure>
    <time_frame>48 hours after treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24 hour sustained pain-free rate</measure>
    <time_frame>24 hours after treatment initiation</time_frame>
    <description>percentage of subjects remaining pain-free</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>48 hour sustained pain-free rate</measure>
    <time_frame>48 hours after treatment initiation</time_frame>
    <description>percentage of subjects remaining pain-free</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to meaningful relief</measure>
    <time_frame>4 hours post-treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nausea, photophobia, phonophobia, vomiting and disability</measure>
    <time_frame>2 hours post-treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject global impression</measure>
    <time_frame>48 hours post-treatment initiation.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of rescue medication</measure>
    <time_frame>48 hours post-treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency, severity, device-relationship and outcome of all adverse events</measure>
    <time_frame>48 hours post-treatment initiation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Acute Migraine</condition>
  <arm_group>
    <arm_group_label>Chordate System S020 in treatment mode</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Chordate System S020 in placebo mode</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Chordate System S020 in treatment mode</intervention_name>
    <arm_group_label>Chordate System S020 in treatment mode</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Chordate System S020 in placebo mode</intervention_name>
    <arm_group_label>Chordate System S020 in placebo mode</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with migraine, with or without aura according to International Headache&#xD;
             Society (IHS) classification (International Classification of Headache Disorders&#xD;
             [ICHD]-III beta).&#xD;
&#xD;
          -  History of 1 to 6 migraine attacks per month for at least 12 previous months.&#xD;
&#xD;
          -  At least 50% of previous migraine attacks had moderate or severe pain intensity.&#xD;
&#xD;
          -  History of at least 48 hours of freedom from headache between migraine attacks.&#xD;
&#xD;
          -  The majority of the previous untreated migraine attacks lasted at least 8 hours.&#xD;
&#xD;
          -  Migraine onset before the age of 50 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History (within one year prior to inclusion into this clinical investigation) of 15 or&#xD;
             more headache days per month (i.e. headaches of any kind).&#xD;
&#xD;
          -  More than 6 days per month with non-migraine headaches (within one year prior to&#xD;
             inclusion into this clinical investigation).&#xD;
&#xD;
          -  Unable to distinguish between migraine headaches and other headache types at the onset&#xD;
             of a migraine attack.&#xD;
&#xD;
          -  Treatment with Botox in the head/neck area within 6 months of the screening visit, or&#xD;
             between the screening and treatment visit.&#xD;
&#xD;
          -  Previously treated with an implantable stimulator or any implantable devices in the&#xD;
             head and/or neck.&#xD;
&#xD;
          -  Pronounced anterior septal nasal deviation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hans-Christoph Diener, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Essen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen / Zentrum für Neurologie</name>
      <address>
        <city>Tübingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie</name>
      <address>
        <city>Erding</city>
        <state>Bayern</state>
        <zip>85435</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologie- &amp; Kopfschmerzzentrum</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>80802</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Großhadern / Neurologische Klinik der Universität München</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Migräne-Klinik Königstein</name>
      <address>
        <city>Konigstein im Taunus</city>
        <state>Hessen</state>
        <zip>61462</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen / Neurologische Klinik</name>
      <address>
        <city>Essen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis für spezielle Schmerztherapie</name>
      <address>
        <city>Wegberg</city>
        <state>Nordrhein-Westfalen</state>
        <zip>41844</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>August 3, 2015</last_update_submitted>
  <last_update_submitted_qc>August 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_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/NCT02185703
org study id: PM004
nct id: NCT02185703
lead sponsor: 
has dmc: No
The main purpose of the study is to evaluate the impact of treatment with the Chordate System
      S020 (medical device) on acute migraine headache pain.
One single migraine attack will be treated either with the Chordate System S020 or with
      Chordate System in placebo mode.

      After a screening visit, up to 3 months before treatment, eligible subjects will be asked to
      return to the center at the onset of their next moderate to severe migraine attack. Subjects
      will be re-checked for eligibility, randomized and treated at the center (treatment visit).
      The subjects will record their response over the next 48 hours using a diary card. A
      follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects
      will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to
      discuss their health including new or ongoing AEs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Headache relief
time frame: 2 hours after treatment initiation
description: Percentage of subjects with a decrease in migraine headache pain from severe or moderate prior treatment to mild or none at 2 hours after treatment initiation with no use of rescue medication during this time period.
measure: Pain-free rate
time frame: 2 hours after treatment initiation
description: Percentage of subjects pain-free (pain intensity rated 'No pain') at 2 hours after treatment initiation with no use of rescue medication.
measure: Incidence of recurrence
time frame: 48 hours after treatment initiation
measure: 24 hour sustained pain-free rate
time frame: 24 hours after treatment initiation
description: percentage of subjects remaining pain-free
measure: 48 hour sustained pain-free rate
time frame: 48 hours after treatment initiation
description: percentage of subjects remaining pain-free
measure: Time to meaningful relief
time frame: 4 hours post-treatment initiation
measure: Change in nausea, photophobia, phonophobia, vomiting and disability
time frame: 2 hours post-treatment initiation
measure: Subject global impression
time frame: 48 hours post-treatment initiation.
measure: Use of rescue medication
time frame: 48 hours post-treatment initiation
measure: Frequency, severity, device-relationship and outcome of all adverse events
time frame: 48 hours post-treatment initiation
arm group label: Chordate System S020 in treatment mode
arm group type: Experimental
arm group label: Chordate System S020 in placebo mode
arm group type: Sham Comparator
intervention type: Device
intervention name: Chordate System S020 in treatment mode
arm group label: Chordate System S020 in treatment mode
intervention type: Device
intervention name: Chordate System S020 in placebo mode
arm group label: Chordate System S020 in placebo mode
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hans-Christoph Diener, Prof. Dr.
role: Principal Investigator
affiliation: Universitätsklinikum Essen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Migraine Disorders