<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/NCT02243865</url>
  </required_header>
  <id_info>
    <org_study_id>PM005</org_study_id>
    <nct_id>NCT02243865</nct_id>
  </id_info>
  <brief_title>Chordate System Prophylactic Migraine Clinical Investigation</brief_title>
  <official_title>A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Prophylactic Effect and Tolerability of Intranasal Kinetic Oscillation Stimulation (KOS) Using the Chordate System S200 in Migraine Patients</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 purpose of this pilot study is to evaluate the performance of the Chordate System, in&#xD;
      terms of the prophylactic effect and tolerability of treatment in patients diagnosed with&#xD;
      migraine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a prospective, interventional, randomized, placebo-controlled, double-blind,&#xD;
      multi-center clinical investigation of a medical device system.&#xD;
&#xD;
      A pilot study in which patients with frequent migraine attacks received intranasal KOS or&#xD;
      placebo using the Chordate System S200 on two occasions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">August 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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>A placebo module, with one input and 6 outputs, was added to the Chordate S200 system. Some outputs delivered active treatment and others placebo. The operator received a coded envelope and according to that, either active treatment or placebo was selected. The operator did not know which outputs delivered treatment and which did not.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration</measure>
    <time_frame>From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)</time_frame>
    <description>A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula:&#xD;
Number of migraine days = (Number of migraine days x 28) / Number of days observed&#xD;
If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis.&#xD;
The change from baseline in number of migraine days was calculated as follows:&#xD;
Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period&#xD;
As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration</measure>
    <time_frame>From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)</time_frame>
    <description>A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If the full time period for either baseline or post treatment period was not documented number of migraine days was recalculated with the formula:&#xD;
Number of migraine days = (Number of migraine days x 28) / Number of days observed&#xD;
If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from the analysis of that time period.&#xD;
The change from baseline in number of migraine days was calculated as follows:&#xD;
Change = number of migraine days per four weeks for applicable post treatment period - number of migraine days per four weeks of the baseline period&#xD;
As the difference between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder Rate</measure>
    <time_frame>From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)</time_frame>
    <description>&quot;Responder&quot; defined as a patient with 50% or greater decrease in the number of migraine days per four weeks, for the 1st, 2nd and 3rd month post treatment vs baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration</measure>
    <time_frame>From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)</time_frame>
    <description>A diary was used where patients added information on the maximum pain intensity on each day according to a 4-point categorical scale (none, mild, medium, severe).&#xD;
The maximum documented pain intensity for each patient during each post treatment time period was tabulated for the active treatment and placebo groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration</measure>
    <time_frame>From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)</time_frame>
    <description>A diary was used where patients added information each day on the number of hours with migraine. The median migraine duration in hours per day was determined for each patient, for each post treatment time period. Baseline for each patient was defined as the median number of migraine hours/day from Day -29 until Day -1, i.e. the day before the first treatment (Day 1).&#xD;
The change in median migraine hours/day from baseline, for each defined post treatment time period, was then determined and the mean change is presented.&#xD;
As the differences between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine hours/day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration</measure>
    <time_frame>From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)</measure>
    <time_frame>At visit 4 day 98, ± 7 days</time_frame>
    <description>Patient satisfaction, evaluated by a clinician, was measured using 8-point clinical global impression (CGI) scores on an improvement scale (CGI-I: compared to condition at baseline, how much has changed: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration</measure>
    <time_frame>From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)</time_frame>
    <description>Number of Participants with a Change in Disease-specific Quality of Life, as measured by EQ-5D-3L, from Baseline (day 0, visit 2 before first treatment) to End of the Three Month Investigation Duration. EQ-5D-3L uses 5 categorical dimensions - motility, self-care, usual activities, pain/discomfort and anxiety/depression, each classified as improved, no change or worsened.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration</measure>
    <time_frame>From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)</time_frame>
    <description>Disease-specific quality of life, as measured by EQ-VAS, at baseline (day 0, visit 2 before first treatment) and at end of the three month study duration after treatment. The EQ VAS is a standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a score from 0-100, where a higher score indicates greater pain intensity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Chordate S200 + control module (CT100), active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chordate System S200 giving Kinetic Oscillation Stimulation Treatment for 15 minutes in each nostril</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chordate S200 + control module (CT100), placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Chordate System S200 giving Kinetic Oscillation Stimulation in placebo mode. Non-inflated and non-vibrating treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Chordate System S200 + CT100 (active treatment)</intervention_name>
    <description>Chordate S200 + CT100 (active treatment) gives Kinetic Oscillation Stimulation for 15 minutes to each nostril and by that giving an effect on the autonomic nervous system (ANS).</description>
    <arm_group_label>Chordate S200 + control module (CT100), active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Chordate System S200 + CT100 (placebo treatment)</intervention_name>
    <description>Chordate S200 + CT100 (placebo) is used in the same way as Active treatment, but no Kinetic Oscillation Stimulation is given. Catheter is not inflated and no vibration is given.</description>
    <arm_group_label>Chordate S200 + control module (CT100), placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject is legally competent, has been informed of the nature, the scope and the&#xD;
             relevance of the study, voluntarily agrees to participation and the study's&#xD;
             provisions, and has duly signed the Informed Consent Form (ICF).&#xD;
&#xD;
          -  Male or female aged between 18 and 65 years&#xD;
&#xD;
          -  Diagnosed as suffering from migraine with or without aura according to International&#xD;
             Headache Society´s (IHS) classification (International Classification of Headache&#xD;
             Disorders (ICHD), 3rd edition, beta version)&#xD;
&#xD;
          -  Reported history of 3 to 8 migraine episodes per month during previous 2 months,&#xD;
             confirmed during baseline&#xD;
&#xD;
          -  Reported history of at least 48 hours of freedom from headache between migraine&#xD;
             attacks, confirmed during baseline&#xD;
&#xD;
          -  Onset of migraine headache occurred before age 50&#xD;
&#xD;
          -  Reported history of migraine for more than one year&#xD;
&#xD;
          -  Reported stable dose of prophylactic migraine medication(s), if any, during the two&#xD;
             months prior to screening (visit 1), and willing and able to maintain stable dose(s)&#xD;
             until the three months follow-up (visit 4)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meeting the ICHD criteria for medication overuse&#xD;
&#xD;
          -  Reported history of 15 or more headache days per month (i.e. headaches of any kind),&#xD;
             confirmed during baseline&#xD;
&#xD;
          -  Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed&#xD;
             during baseline&#xD;
&#xD;
          -  Unable to distinguish between migraine headaches and other headache types&#xD;
&#xD;
          -  Treatment with Botox received within 6 months of the screening visit, or between the&#xD;
             screening and treatment visits&#xD;
&#xD;
          -  Ongoing treatment with implanted stimulator or other implanted device in the head&#xD;
             and/or neck region&#xD;
&#xD;
          -  Known pronounced anterior septal deviation, or other known relevant abnormality in the&#xD;
             nasal cavity, including bacterial infection and wounds&#xD;
&#xD;
          -  History of sinus surgery, transphenoidal surgery for pituitary or other lesions or&#xD;
             cerebrospinal fluid (CSF) rhinorrhea&#xD;
&#xD;
          -  Fitted with a pacemaker/defibrillator&#xD;
&#xD;
          -  Previously treated with therapeutic radiation to the face (that could have influenced&#xD;
             the nasal mucosa)&#xD;
&#xD;
          -  Ongoing upper respiratory tract infection or a body temperature &gt;38.5°C (at&#xD;
             treatment), or malignancy in the nasal cavity&#xD;
&#xD;
          -  History of regular nose bleeding (epistaxis), or concomitant condition that could&#xD;
             cause excessive bleeding, including treatment with the anticoagulant Varan&#xD;
&#xD;
          -  Head injury or open wound that contraindicates use of Chordate Headband&#xD;
&#xD;
          -  Known allergy to polyvinylchloride, a material used in the Catheter, or medicinal&#xD;
             liquid paraffin&#xD;
&#xD;
          -  Concurrent condition or risk of non-compliance that, in the investigator's opinion,&#xD;
             may affect the interpretation of performance or safety data or which otherwise&#xD;
             contraindicates participation in a clinical investigation&#xD;
&#xD;
          -  Any change in migraine prophylaxis the previous two months&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Participation in a clinical research study within three months of enrolment or planned&#xD;
             participation at any time during this clinical investigation&#xD;
&#xD;
          -  Employees of the study site or the sponsor directly involved with the conduct of the&#xD;
             study, or immediate family members or any such individuals&#xD;
&#xD;
          -  Headache or migraine episode within the 48 hours prior to the first treatment&#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>Jan-Åke Åkesson, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stortorgets neurologmottagning</name>
      <address>
        <city>Helsingborg</city>
        <zip>25220</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Läkarcentrum Stångåblick</name>
      <address>
        <city>Linköping</city>
        <zip>582 19</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurolgy Clinic</name>
      <address>
        <city>Stockholm</city>
        <zip>11433</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologmottagningen Vällingby sjukhus</name>
      <address>
        <city>Vällingby</city>
        <zip>162 68</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <results_first_submitted>July 26, 2016</results_first_submitted>
  <results_first_submitted_qc>October 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 8, 2021</results_first_posted>
  <last_update_submitted>October 11, 2021</last_update_submitted>
  <last_update_submitted_qc>October 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Chordate System S200 + CT100 (Active) Treatment</title>
          <description>Chordate System S200 + control module (CT100), active treatment: 44 subjects</description>
        </group>
        <group group_id="P2">
          <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
          <description>Chordate System S200 + control module (CT100), placebo treatment: 38 subjects</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Chordate System S200 + CT100 (Active Treatment)</title>
          <description>Chordate System S200 + CT100 (active treatment) is Kinetic Oscillation Stimulation (KOS) treatment with the Chordate System S200 + CT100</description>
        </group>
        <group group_id="B2">
          <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
          <description>Chordate System S200 + CT100 (placebo treatment), is Placebo treatment with the Chordate System S200 + CT100 without an inflated catheter and without vibrations</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="44"/>
            <count group_id="B2" value="43"/>
            <count group_id="B3" value="87"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.6" spread="11.7"/>
                    <measurement group_id="B2" value="49.0" spread="10.5"/>
                    <measurement group_id="B3" value="47.3" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration</title>
        <description>A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula:&#xD;
Number of migraine days = (Number of migraine days x 28) / Number of days observed&#xD;
If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis.&#xD;
The change from baseline in number of migraine days was calculated as follows:&#xD;
Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period&#xD;
As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.</description>
        <time_frame>From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)</time_frame>
        <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment. Only patients who completed treatment were included in analysis (see participant flow).</population>
        <group_list>
          <group group_id="O1">
            <title>Chordate System S200 + CT100 (Active Treatment)</title>
            <description>Chordate System S200 + CT100 (active treatment): 44 subjects</description>
          </group>
          <group group_id="O2">
            <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
            <description>Chordate System S200 + CT100 (placebo treatment): 43 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration</title>
          <description>A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula:&#xD;
Number of migraine days = (Number of migraine days x 28) / Number of days observed&#xD;
If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis.&#xD;
The change from baseline in number of migraine days was calculated as follows:&#xD;
Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period&#xD;
As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.</description>
          <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment. Only patients who completed treatment were included in analysis (see participant flow).</population>
          <units>Migraine days/four weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="3.6"/>
                    <measurement group_id="O2" value="-1.3" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6938</p_value>
            <method>ANCOVA</method>
            <method_desc>In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration</title>
        <description>A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If the full time period for either baseline or post treatment period was not documented number of migraine days was recalculated with the formula:&#xD;
Number of migraine days = (Number of migraine days x 28) / Number of days observed&#xD;
If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from the analysis of that time period.&#xD;
The change from baseline in number of migraine days was calculated as follows:&#xD;
Change = number of migraine days per four weeks for applicable post treatment period - number of migraine days per four weeks of the baseline period&#xD;
As the difference between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.</description>
        <time_frame>From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)</time_frame>
        <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Chordate System S200 + CT100 (Active Treatment)</title>
            <description>Chordate System S200 + CT100 (active treatment): 44 subjects</description>
          </group>
          <group group_id="O2">
            <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
            <description>Chordate System S200 + CT100 (placebo treatment): 43 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration</title>
          <description>A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If the full time period for either baseline or post treatment period was not documented number of migraine days was recalculated with the formula:&#xD;
Number of migraine days = (Number of migraine days x 28) / Number of days observed&#xD;
If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from the analysis of that time period.&#xD;
The change from baseline in number of migraine days was calculated as follows:&#xD;
Change = number of migraine days per four weeks for applicable post treatment period - number of migraine days per four weeks of the baseline period&#xD;
As the difference between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.</description>
          <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.</population>
          <units>Migraine days/four weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="3.9"/>
                    <measurement group_id="O2" value="-1.1" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="4.0"/>
                    <measurement group_id="O2" value="-0.8" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="4.1"/>
                    <measurement group_id="O2" value="-2.2" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="4.4"/>
                    <measurement group_id="O2" value="-1.7" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 1st month of the three month post treatment investigation duration</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6557</p_value>
            <method>ANCOVA</method>
            <method_desc>In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 2nd month of the three month post treatment investigation duration</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.515</p_value>
            <method>ANCOVA</method>
            <method_desc>In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 3rd month of the three month post treatment investigation duration</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3256</p_value>
            <method>ANCOVA</method>
            <method_desc>In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the final four weeks of the three month post treatment investigation duration.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4086</p_value>
            <method>ANCOVA</method>
            <method_desc>In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Responder Rate</title>
        <description>&quot;Responder&quot; defined as a patient with 50% or greater decrease in the number of migraine days per four weeks, for the 1st, 2nd and 3rd month post treatment vs baseline</description>
        <time_frame>From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)</time_frame>
        <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Chordate System S200 + CT100 (Active Treatment)</title>
            <description>Chordate System S200 + CT100 (active treatment): 44 subjects</description>
          </group>
          <group group_id="O2">
            <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
            <description>Chordate System S200 + CT100 (placebo treatment): 43 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Responder Rate</title>
          <description>&quot;Responder&quot; defined as a patient with 50% or greater decrease in the number of migraine days per four weeks, for the 1st, 2nd and 3rd month post treatment vs baseline</description>
          <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration</title>
        <description>A diary was used where patients added information on the maximum pain intensity on each day according to a 4-point categorical scale (none, mild, medium, severe).&#xD;
The maximum documented pain intensity for each patient during each post treatment time period was tabulated for the active treatment and placebo groups.</description>
        <time_frame>From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)</time_frame>
        <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Chordate System S200 + CT100 (Active Treatment)</title>
            <description>Chordate System S200 + CT100 (active treatment): 44 subjects</description>
          </group>
          <group group_id="O2">
            <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
            <description>Chordate System S200 + CT100 (placebo treatment): 43 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration</title>
          <description>A diary was used where patients added information on the maximum pain intensity on each day according to a 4-point categorical scale (none, mild, medium, severe).&#xD;
The maximum documented pain intensity for each patient during each post treatment time period was tabulated for the active treatment and placebo groups.</description>
          <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final 4 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration</title>
        <description>A diary was used where patients added information each day on the number of hours with migraine. The median migraine duration in hours per day was determined for each patient, for each post treatment time period. Baseline for each patient was defined as the median number of migraine hours/day from Day -29 until Day -1, i.e. the day before the first treatment (Day 1).&#xD;
The change in median migraine hours/day from baseline, for each defined post treatment time period, was then determined and the mean change is presented.&#xD;
As the differences between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine hours/day.</description>
        <time_frame>From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)</time_frame>
        <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Chordate System S200 + CT100 (Active Treatment)</title>
            <description>Chordate System S200 + CT100 (active treatment): 40 subjects</description>
          </group>
          <group group_id="O2">
            <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
            <description>Chordate System S200 + CT100 (placebo treatment): 38 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration</title>
          <description>A diary was used where patients added information each day on the number of hours with migraine. The median migraine duration in hours per day was determined for each patient, for each post treatment time period. Baseline for each patient was defined as the median number of migraine hours/day from Day -29 until Day -1, i.e. the day before the first treatment (Day 1).&#xD;
The change in median migraine hours/day from baseline, for each defined post treatment time period, was then determined and the mean change is presented.&#xD;
As the differences between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine hours/day.</description>
          <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.</population>
          <units>Hours / day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="3.3"/>
                    <measurement group_id="O2" value="0.1" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="3.9"/>
                    <measurement group_id="O2" value="1.3" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="5.1"/>
                    <measurement group_id="O2" value="-0.4" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final 4 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="5.7"/>
                    <measurement group_id="O2" value="0.0" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="3.4"/>
                    <measurement group_id="O2" value="0.2" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration</title>
        <time_frame>From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)</time_frame>
        <population>No statistical analysis was done; only tabular listing. All patients that completed treatment were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Chordate System S200 + CT100 (Active Treatment)</title>
            <description>Chordate System S200 + CT100 (active treatment): 44 subjects</description>
          </group>
          <group group_id="O2">
            <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
            <description>Chordate System S200 + CT100 (placebo treatment): 43 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration</title>
          <population>No statistical analysis was done; only tabular listing. All patients that completed treatment were included.</population>
          <units>Number of medications</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)</title>
        <description>Patient satisfaction, evaluated by a clinician, was measured using 8-point clinical global impression (CGI) scores on an improvement scale (CGI-I: compared to condition at baseline, how much has changed: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse).</description>
        <time_frame>At visit 4 day 98, ± 7 days</time_frame>
        <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Chordate System S200 + CT100 (Active Treatment)</title>
            <description>Chordate System S200 + CT100 (active treatment): 44 subjects</description>
          </group>
          <group group_id="O2">
            <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
            <description>Chordate System S200 + CT100 (placebo treatment): 43 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)</title>
          <description>Patient satisfaction, evaluated by a clinician, was measured using 8-point clinical global impression (CGI) scores on an improvement scale (CGI-I: compared to condition at baseline, how much has changed: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse).</description>
          <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very much improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minimally improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minimally worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration</title>
        <description>Number of Participants with a Change in Disease-specific Quality of Life, as measured by EQ-5D-3L, from Baseline (day 0, visit 2 before first treatment) to End of the Three Month Investigation Duration. EQ-5D-3L uses 5 categorical dimensions - motility, self-care, usual activities, pain/discomfort and anxiety/depression, each classified as improved, no change or worsened.</description>
        <time_frame>From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)</time_frame>
        <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Chordate System S200 + CT100 (Active Treatment)</title>
            <description>Chordate System S200 + CT100 (active treatment): 44 subjects</description>
          </group>
          <group group_id="O2">
            <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
            <description>Chordate System S200 + CT100 (placebo treatment): 43 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration</title>
          <description>Number of Participants with a Change in Disease-specific Quality of Life, as measured by EQ-5D-3L, from Baseline (day 0, visit 2 before first treatment) to End of the Three Month Investigation Duration. EQ-5D-3L uses 5 categorical dimensions - motility, self-care, usual activities, pain/discomfort and anxiety/depression, each classified as improved, no change or worsened.</description>
          <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Motility</title>
              <category_list>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Worsened</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-care</title>
              <category_list>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Worsened</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual activities</title>
              <category_list>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Worsened</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort</title>
              <category_list>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Worsened</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression</title>
              <category_list>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Worsened</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration</title>
        <description>Disease-specific quality of life, as measured by EQ-VAS, at baseline (day 0, visit 2 before first treatment) and at end of the three month study duration after treatment. The EQ VAS is a standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a score from 0-100, where a higher score indicates greater pain intensity.</description>
        <time_frame>From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)</time_frame>
        <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Chordate System S200 + CT100 (Active Treatment)</title>
            <description>Chordate System S200 + CT100 (active treatment): 44 subjects</description>
          </group>
          <group group_id="O2">
            <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
            <description>Chordate System S200 + CT100 (placebo treatment): 43 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration</title>
          <description>Disease-specific quality of life, as measured by EQ-VAS, at baseline (day 0, visit 2 before first treatment) and at end of the three month study duration after treatment. The EQ VAS is a standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a score from 0-100, where a higher score indicates greater pain intensity.</description>
          <population>44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VAS Pain score at visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.7" spread="15.0"/>
                    <measurement group_id="O2" value="80.6" spread="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS pain score at visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8" spread="14.5"/>
                    <measurement group_id="O2" value="79.8" spread="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Chordate System S200 + CT100 (Active Treatment)</title>
          <description>Chordate System S200 + CT100 (active treatment): 44 subjects</description>
        </group>
        <group group_id="E2">
          <title>Chordate System S200 + CT100 (Placebo Treatment)</title>
          <description>Chordate System S200 + CT100 (placebo treatment): 43 subjects</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (8.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Laminar hole of the macula</sub_title>
                <description>Pat P7-05 presented with laminar hole of the macula of the right Eye 5 weeks after treatment.The event was assessed as not related to the device and related to the procedure. Conc. diseases were hypertension, dyspepsia and optic neuritis left Eye.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (8.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Increased tear secretion</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Increased nasal secretion</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Mild burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Paraesthesia of the lip</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Slight discomfort</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Slight pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Jan-Åke Åkesson</name_or_title>
      <organization>Chordate</organization>
      <phone>+46 8 40015586</phone>
      <email>info@chordate.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02243865
org study id: PM005
nct id: NCT02243865
lead sponsor: 
has dmc: No
The purpose of this pilot study is to evaluate the performance of the Chordate System, in
      terms of the prophylactic effect and tolerability of treatment in patients diagnosed with
      migraine.
This was a prospective, interventional, randomized, placebo-controlled, double-blind,
      multi-center clinical investigation of a medical device system.

      A pilot study in which patients with frequent migraine attacks received intranasal KOS or
      placebo using the Chordate System S200 on two occasions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: A placebo module, with one input and 6 outputs, was added to the Chordate S200 system. Some outputs delivered active treatment and others placebo. The operator received a coded envelope and according to that, either active treatment or placebo was selected. The operator did not know which outputs delivered treatment and which did not.
measure: Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration
time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
description: A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula:
Number of migraine days = (Number of migraine days x 28) / Number of days observed
If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis.
The change from baseline in number of migraine days was calculated as follows:
Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period
As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.
measure: Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration
time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
description: A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If the full time period for either baseline or post treatment period was not documented number of migraine days was recalculated with the formula:
Number of migraine days = (Number of migraine days x 28) / Number of days observed
If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from the analysis of that time period.
The change from baseline in number of migraine days was calculated as follows:
Change = number of migraine days per four weeks for applicable post treatment period - number of migraine days per four weeks of the baseline period
As the difference between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.
measure: Responder Rate
time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
description: "Responder" defined as a patient with 50% or greater decrease in the number of migraine days per four weeks, for the 1st, 2nd and 3rd month post treatment vs baseline
measure: Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
time frame: From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)
description: A diary was used where patients added information on the maximum pain intensity on each day according to a 4-point categorical scale (none, mild, medium, severe).
The maximum documented pain intensity for each patient during each post treatment time period was tabulated for the active treatment and placebo groups.
measure: Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
description: A diary was used where patients added information each day on the number of hours with migraine. The median migraine duration in hours per day was determined for each patient, for each post treatment time period. Baseline for each patient was defined as the median number of migraine hours/day from Day -29 until Day -1, i.e. the day before the first treatment (Day 1).
The change in median migraine hours/day from baseline, for each defined post treatment time period, was then determined and the mean change is presented.
As the differences between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine hours/day.
measure: Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration
time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
measure: Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
time frame: At visit 4 day 98, ± 7 days
description: Patient satisfaction, evaluated by a clinician, was measured using 8-point clinical global impression (CGI) scores on an improvement scale (CGI-I: compared to condition at baseline, how much has changed: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse).
measure: Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
time frame: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
description: Number of Participants with a Change in Disease-specific Quality of Life, as measured by EQ-5D-3L, from Baseline (day 0, visit 2 before first treatment) to End of the Three Month Investigation Duration. EQ-5D-3L uses 5 categorical dimensions - motility, self-care, usual activities, pain/discomfort and anxiety/depression, each classified as improved, no change or worsened.
measure: Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration
time frame: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
description: Disease-specific quality of life, as measured by EQ-VAS, at baseline (day 0, visit 2 before first treatment) and at end of the three month study duration after treatment. The EQ VAS is a standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a score from 0-100, where a higher score indicates greater pain intensity.
arm group label: Chordate S200 + control module (CT100), active
arm group type: Experimental
description: Chordate System S200 giving Kinetic Oscillation Stimulation Treatment for 15 minutes in each nostril
arm group label: Chordate S200 + control module (CT100), placebo
arm group type: Placebo Comparator
description: Chordate System S200 giving Kinetic Oscillation Stimulation in placebo mode. Non-inflated and non-vibrating treatment
intervention type: Device
intervention name: Chordate System S200 + CT100 (active treatment)
description: Chordate S200 + CT100 (active treatment) gives Kinetic Oscillation Stimulation for 15 minutes to each nostril and by that giving an effect on the autonomic nervous system (ANS).
arm group label: Chordate S200 + control module (CT100), active
intervention type: Device
intervention name: Chordate System S200 + CT100 (placebo treatment)
description: Chordate S200 + CT100 (placebo) is used in the same way as Active treatment, but no Kinetic Oscillation Stimulation is given. Catheter is not inflated and no vibration is given.
arm group label: Chordate S200 + control module (CT100), placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jan-Åke Åkesson, MD
role: Study Chair
affiliation: Linkoeping University
facility: 
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Migraine Disorders
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 