<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/NCT03036761</url>
  </required_header>
  <id_info>
    <org_study_id>2016/58</org_study_id>
    <secondary_id>2016-A01534-47</secondary_id>
    <nct_id>NCT03036761</nct_id>
  </id_info>
  <brief_title>Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines</brief_title>
  <acronym>Migauric</acronym>
  <official_title>Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to show that auriculotherapy decreases the number of days with&#xD;
      painful episodes of migraine and headache after 3 months of treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, multicenter, controlled and randomized study.&#xD;
&#xD;
      At the inclusion:&#xD;
&#xD;
        -  initial assessment of migraine and headache attacks of the last 3 months with the&#xD;
           migraine/headache/treatment diary;&#xD;
&#xD;
        -  quality of life assessment (MIDAS questionnaire).&#xD;
&#xD;
      Patients are randomized in 2 groups (distribution 2/3 AUR+, 1/3 AUR-):&#xD;
&#xD;
        -  AUR+: experimental group &quot;Auriculotherapy&quot;. Patients benefit from 3 sessions of&#xD;
           auriculotherapy at one month intervals.&#xD;
&#xD;
        -  AUR-: control group. Patients do not benefit from auriculotherapy.&#xD;
&#xD;
      After 3 months, a visit of Algology is carried out :&#xD;
&#xD;
        -  final assessment of migraine and headache attacks of the last 3 months with the&#xD;
           migraine/headache/treatment diary;&#xD;
&#xD;
        -  quality of life assessment (MIDAS questionnaire).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">March 22, 2021</completion_date>
  <primary_completion_date type="Actual">December 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of days with migraine and non-migraine headache post inclusion.</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.&#xD;
One day with painful episodes of migraines and non-migraines headaches is a day when:&#xD;
the pain episode lasts more than 4 hours,&#xD;
or the pain episode is suppressed by a specific treatment known to the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of days with migraine post inclusion.</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluated with the patient's migraine/headache/treatment diay of the last 3 months after inclusion.&#xD;
One day with painful episodes of migraines is a day when:&#xD;
the pain episode lasts more than 4 hours,&#xD;
or the pain episode is suppressed by a specific treatment known to the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days with non migraine headache post inclusion.</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.&#xD;
One day with painful episodes of non-migraines headaches is a day when:&#xD;
the pain episode lasts more than 4 hours,&#xD;
or the pain episode is suppressed by a specific treatment known to the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale</measure>
    <time_frame>3 months</time_frame>
    <description>The intensity of the pain episodes is evaluated by the patient on a numerical scale of 1 to 3 (1 = low, 2 = moderate, 3 = intense) which is in the patient's migraine/headache/treatment diary of the 3 months after inclusion.&#xD;
The outcome is evaluated by the calculation of the sum of the pain intensities of migraines and non-migraine headaches .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of antalgic use (triptan and non-triptan) in migraine patients.</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.&#xD;
The sum of antalgic use (triptan and non-triptan):&#xD;
total number of triptan taken;&#xD;
number of days with triptan;&#xD;
total number of non-triptan analgesics taken;&#xD;
number of days with non-triptan analgesics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the quality of life of the patient: MIDAS score</measure>
    <time_frame>3 months</time_frame>
    <description>Calculation of the MIDAS score during the inclusion visit and 3 months after the inclusion visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of auriculotherapy treatment</measure>
    <time_frame>3 months</time_frame>
    <description>The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Headache, Migraine</condition>
  <arm_group>
    <arm_group_label>AUR+: Auriculotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients benefit from 3 sessions of auriculotherapy at one month intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AUR-: No auriculotherapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients do not benefit from auriculotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Auriculotherapy</intervention_name>
    <description>3 sessions of auriculotherapy at one month intervals.</description>
    <arm_group_label>AUR+: Auriculotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman;&#xD;
&#xD;
          -  Aged from 18 to 80;&#xD;
&#xD;
          -  Benefiting from social security scheme or legal successor;&#xD;
&#xD;
          -  Having given their non-opposition to the study; ·&#xD;
&#xD;
          -  Diagnosis of chronical migraine for more than 6 months;&#xD;
&#xD;
          -  Without background treatment or with stable background therapy for more than 1 month;&#xD;
&#xD;
          -  Presenting a calendar of migraines and headaches mentioning the number of days with&#xD;
             pain, intensity of pain and treatments for at least 3 months.&#xD;
&#xD;
        Non inclusion Criteria:&#xD;
&#xD;
          -  Man;&#xD;
&#xD;
          -  Patient with less than 6 painful episodes in 3 months;&#xD;
&#xD;
          -  History or actual mental health disorder;&#xD;
&#xD;
          -  Dependence on opioids or tranquillizers;&#xD;
&#xD;
          -  Secondary headaches;&#xD;
&#xD;
          -  Incapacitated to keep a diary of the migraines / headaches / treatments;&#xD;
&#xD;
          -  Contraindications for the use of auriculotherapy (scheduled Magnetic resonance imaging&#xD;
             examination, declared pregnancy, breastfeeding, artificial heart valves, Haemophilia,&#xD;
             effective anticoagulation treatment);&#xD;
&#xD;
          -  Having received auriculotherapy treatment in the indication of the study in the last&#xD;
             12 months before inclusion;&#xD;
&#xD;
          -  Scheduled to start a new drug or non-drug therapy which could interfere with the study&#xD;
             (antidepressant, opioids, anticonvulsant psychological therapy, physiotherapy, deep&#xD;
             brain stimulation, etc..);&#xD;
&#xD;
          -  Modification of background treatment during the month before inclusion.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Allergy or infection of the auricle&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Woman</gender_description>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mireille Michel-Cherqui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cabinet Médical</name>
      <address>
        <city>Maisons-Alfort</city>
        <zip>94700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Médical de L'Olivier</name>
      <address>
        <city>Montigny-le-Bretonneux</city>
        <zip>78180</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHP Saint Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>April 20, 2021</last_update_submitted>
  <last_update_submitted_qc>April 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Auriculotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036761
org study id: 2016/58
secondary id: 2016-A01534-47
nct id: NCT03036761
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to show that auriculotherapy decreases the number of days with
      painful episodes of migraine and headache after 3 months of treatment
Prospective, multicenter, controlled and randomized study.

      At the inclusion:

        -  initial assessment of migraine and headache attacks of the last 3 months with the
           migraine/headache/treatment diary;

        -  quality of life assessment (MIDAS questionnaire).

      Patients are randomized in 2 groups (distribution 2/3 AUR+, 1/3 AUR-):

        -  AUR+: experimental group "Auriculotherapy". Patients benefit from 3 sessions of
           auriculotherapy at one month intervals.

        -  AUR-: control group. Patients do not benefit from auriculotherapy.

      After 3 months, a visit of Algology is carried out :

        -  final assessment of migraine and headache attacks of the last 3 months with the
           migraine/headache/treatment diary;

        -  quality of life assessment (MIDAS questionnaire).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of days with migraine and non-migraine headache post inclusion.
time frame: 3 months
description: Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.
One day with painful episodes of migraines and non-migraines headaches is a day when:
the pain episode lasts more than 4 hours,
or the pain episode is suppressed by a specific treatment known to the patient.
measure: Number of days with migraine post inclusion.
time frame: 3 months
description: Evaluated with the patient's migraine/headache/treatment diay of the last 3 months after inclusion.
One day with painful episodes of migraines is a day when:
the pain episode lasts more than 4 hours,
or the pain episode is suppressed by a specific treatment known to the patient.
measure: Number of days with non migraine headache post inclusion.
time frame: 3 months
description: Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.
One day with painful episodes of non-migraines headaches is a day when:
the pain episode lasts more than 4 hours,
or the pain episode is suppressed by a specific treatment known to the patient.
measure: Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale
time frame: 3 months
description: The intensity of the pain episodes is evaluated by the patient on a numerical scale of 1 to 3 (1 = low, 2 = moderate, 3 = intense) which is in the patient's migraine/headache/treatment diary of the 3 months after inclusion.
The outcome is evaluated by the calculation of the sum of the pain intensities of migraines and non-migraine headaches .
measure: Evolution of antalgic use (triptan and non-triptan) in migraine patients.
time frame: 3 months
description: Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.
The sum of antalgic use (triptan and non-triptan):
total number of triptan taken;
number of days with triptan;
total number of non-triptan analgesics taken;
number of days with non-triptan analgesics.
measure: Evaluation of the quality of life of the patient: MIDAS score
time frame: 3 months
description: Calculation of the MIDAS score during the inclusion visit and 3 months after the inclusion visit.
measure: Tolerance of auriculotherapy treatment
time frame: 3 months
description: The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.
arm group label: AUR+: Auriculotherapy
arm group type: Experimental
description: Patients benefit from 3 sessions of auriculotherapy at one month intervals.
arm group label: AUR-: No auriculotherapy
arm group type: No Intervention
description: Patients do not benefit from auriculotherapy.
intervention type: Procedure
intervention name: Auriculotherapy
description: 3 sessions of auriculotherapy at one month intervals.
arm group label: AUR+: Auriculotherapy
criteria: 
gender: Female
gender based: Yes
gender description: Woman
minimum age: 18 Months
maximum age: 80 Years
healthy volunteers: No
last name: Mireille Michel-Cherqui, MD
role: Principal Investigator
affiliation: Hopital Foch
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache