xml: <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/NCT06029153</url>
    </required_header>
    <id_info>
      <org_study_id>FAST-EM</org_study_id>
      <nct_id>NCT06029153</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine</brief_title>
    <acronym>FAST-EM</acronym>
    <official_title>Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine：a Single-arm, Self-control, Open-label, Multicenter Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zeguang Ren</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Affiliated Hospital Of Guizhou Medical University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This study is a single-arm, self-controlled clinical trial that aims to explore and evaluate&#xD;
        the efficacy of middle meningeal artery embolization with coil in improving migraine&#xD;
        symptoms. The main objectives of the study are to record and evaluate the effectiveness and&#xD;
        safety of the treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a single-arm, self-controlled clinical trial that aims to explore and evaluate&#xD;
        the efficacy of middle meningeal artery embolization with coil in improving migraine&#xD;
        symptoms. The inclusion criteria consist of patients with or without aura migraines, who have&#xD;
        experienced persistent, chronic migraines for at least 3 months prior to screening, and have&#xD;
        shown resistance to at least two or more drug treatments, with unsatisfactory therapeutic&#xD;
        effects, intolerable side effects, or contraindications. The main objectives of the study are&#xD;
        to record and evaluate the effectiveness and safety of the treatment.The content that needs&#xD;
        to be recorded includes Headache attack frequency (times / month and Headache&#xD;
        duration),Headache attack frequency (days / month),Days of medication in acute phase and&#xD;
        dosage,Severity of headache,Headache aura(nausea,photophobia,phonophobia) frequency,Migraine&#xD;
        Disability Assessment,Headache Impact,Migraine-Specific Questionnaire,Hospital Anxiety and&#xD;
        Depression Scale,Patient Clinical Global Impression.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Headache attack frequency (times / month and Headache duration）</measure>
      <time_frame>At baseline and 30 days,60 days after treatment</time_frame>
      <description>Record of headache attack frequency (times / month and Headache duration）</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Headache attack frequency (days / month)</measure>
      <time_frame>At baseline, 30 days, and 60 days after treatment</time_frame>
      <description>Record of headache attack frequency (days / month)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days of medication in acute phase and dosage</measure>
      <time_frame>At baseline, 30 days, and 60 days after treatment</time_frame>
      <description>Record of days of medication in acute phase and dosage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severity of headache</measure>
      <time_frame>At baseline,36 hours,day of discharge,30 days,and 60 days after treatment</time_frame>
      <description>VAS/NRS pain rating scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache aura(nausea,photophobia,phonophobia) frequency</measure>
      <time_frame>At baseline,30 days,and 60 days after treatment</time_frame>
      <description>Record of headache aura</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Migraine Disability Assessment</measure>
      <time_frame>At baseline,30 days,and 60 days after treatment</time_frame>
      <description>Migraine Disability Assessment (MIDAS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache Impact</measure>
      <time_frame>At baseline,30 days,and 60 days after treatment</time_frame>
      <description>Headache Impact Test (HIT-6)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Migraine-Specific Questionnaire</measure>
      <time_frame>At baseline,30 days,and 60 days after treatment</time_frame>
      <description>Migraine-Specific Questionnaire（MSQ）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Anxiety and Depression Scale</measure>
      <time_frame>At baseline,30 days,and 60 days after treatment</time_frame>
      <description>Hospital Anxiety and Depression Scale(HADS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Clinical Global Impression</measure>
      <time_frame>Patient Clinical Global Impression</time_frame>
      <description>At baseline,30 days,and 60 days after treatment(PCGI)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Migraine</condition>
    <arm_group>
      <arm_group_label>Middle meningeal artery embolization</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Middle meningeal artery embolization with coil.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Middle meningeal artery embolization</intervention_name>
      <description>Middle meningeal artery embolization with coil.</description>
      <arm_group_label>Middle meningeal artery embolization</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria：&#xD;
  &#xD;
            1. Voluntary written informed consent.&#xD;
  &#xD;
            2. Age 18~80 years old (inclusive), regardless of gender.&#xD;
  &#xD;
            3. Migraine was diagnosed by clinicians, according to The International Classification of&#xD;
               Headache Disorders,3rd Edition&#xD;
  &#xD;
            4. Patients with intractable migraine or refractory headache with migraine duration of&#xD;
               more than 3 months and recurring migraine in the past 90 days before screening.&#xD;
  &#xD;
            5. Patients who take two or more drugs are not satisfied with the therapeutic effect, the&#xD;
               side effects of drug treatment are difficult to tolerate or have contraindications.&#xD;
  &#xD;
            6. Headache frequency should be confirmed within 30 days before screening.&#xD;
  &#xD;
            7. Patients with good compliance, willing and able to follow the requirements of&#xD;
               treatment and follow-up observation.&#xD;
  &#xD;
          Exclusion criteria：&#xD;
  &#xD;
            1. Patients with cervical spondylosis and secondary headaches such as otogenic, nasal,&#xD;
               and odontogenic patients with a history of trigeminal autonomic headache, other&#xD;
               definite causes of headache, or secondary headache.&#xD;
  &#xD;
            2. Patients without suitable vascular access.&#xD;
  &#xD;
            3. Patients scheduled for surgery within 90 days.&#xD;
  &#xD;
            4. The life expectancy of patients is less than 12 months.&#xD;
  &#xD;
            5. History of contrast agent allergy.&#xD;
  &#xD;
            6. Lactating or pregnant women, or patients with a fertility plan within 1 year.&#xD;
  &#xD;
            7. The clinical status of the patient was extremely poor, with an mRS Score ≥4.&#xD;
  &#xD;
            8. Participants who had participated in clinical studies of other drugs or medical&#xD;
               devices before enrollment and did not meet the primary study endpoint time limit.&#xD;
  &#xD;
            9. The investigator judged that the patient had poor compliance and could not complete&#xD;
               the study as required.&#xD;
  &#xD;
           10. The patient had a clear history of allergies to embolic materials such as Nitinol&#xD;
               alloy, cobalt-based alloy, and platinum-tungsten alloy.&#xD;
  &#xD;
           11. Patient was allergic to the contrast agent.&#xD;
  &#xD;
           12. Patients with other diseases limit their participation in the study, cannot follow up,&#xD;
               or affect the scientific integrity of the study.&#xD;
  &#xD;
           13. Patients have clotting disorders or are on anticoagulant therapy.&#xD;
  &#xD;
           14. Patients have a history of opioid addiction.&#xD;
  &#xD;
           15. Researchers believe that patients who are not suitable to participate in this trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zeguang Ren, MD. PhD.</last_name>
      <role>Study Chair</role>
      <affiliation>The Affiliated Hospital Of Guizhou Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zeguang Ren, MD. PhD.</last_name>
      <phone>+8613373419258</phone>
      <email>renzem@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Junshuan Cui, MD.</last_name>
      <phone>+8615761600325</phone>
      <email>junshuan2306@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Affiliated Hospital of Guizhou Medical University</name>
        <address>
          <city>Guiyang</city>
          <state>Guizhou</state>
          <zip>550001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zeguang Ren, MD. PhD.</last_name>
        <phone>+8615761600325</phone>
        <email>renzem@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Junshuan Cui, MD.</last_name>
        <phone>+8615761600325</phone>
        <email>junshuan2306@163.com</email>
      </contact_backup>
      <investigator>
        <last_name>Hua Yang, MD.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kaya Xu, MD. PhD.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Xin Xiang, MD. PhD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Liangzhao Chu, MD. PhD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Junshuan Cui, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The Affiliated Hospital Of Guizhou Medical University</investigator_affiliation>
      <investigator_full_name>Zeguang Ren</investigator_full_name>
      <investigator_title>The Affiliated Hospital Of Guizhou Medical University</investigator_title>
    </responsible_party>
    <keyword>Migraine</keyword>
    <keyword>Middle meningeal artery</keyword>
    <keyword>Ambolization</keyword>
    <keyword>Coil</keyword>
    <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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029153
  org study id: FAST-EM
  nct id: NCT06029153
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is a single-arm, self-controlled clinical trial that aims to explore and evaluate
        the efficacy of middle meningeal artery embolization with coil in improving migraine
        symptoms. The main objectives of the study are to record and evaluate the effectiveness and
        safety of the treatment.
  This study is a single-arm, self-controlled clinical trial that aims to explore and evaluate
        the efficacy of middle meningeal artery embolization with coil in improving migraine
        symptoms. The inclusion criteria consist of patients with or without aura migraines, who have
        experienced persistent, chronic migraines for at least 3 months prior to screening, and have
        shown resistance to at least two or more drug treatments, with unsatisfactory therapeutic
        effects, intolerable side effects, or contraindications. The main objectives of the study are
        to record and evaluate the effectiveness and safety of the treatment.The content that needs
        to be recorded includes Headache attack frequency (times / month and Headache
        duration),Headache attack frequency (days / month),Days of medication in acute phase and
        dosage,Severity of headache,Headache aura(nausea,photophobia,phonophobia) frequency,Migraine
        Disability Assessment,Headache Impact,Migraine-Specific Questionnaire,Hospital Anxiety and
        Depression Scale,Patient Clinical Global Impression.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Headache attack frequency (times / month and Headache duration）
  time frame: At baseline and 30 days,60 days after treatment
  description: Record of headache attack frequency (times / month and Headache duration）
  measure: Headache attack frequency (days / month)
  time frame: At baseline, 30 days, and 60 days after treatment
  description: Record of headache attack frequency (days / month)
  measure: Days of medication in acute phase and dosage
  time frame: At baseline, 30 days, and 60 days after treatment
  description: Record of days of medication in acute phase and dosage
  measure: Severity of headache
  time frame: At baseline,36 hours,day of discharge,30 days,and 60 days after treatment
  description: VAS/NRS pain rating scale
  measure: Headache aura(nausea,photophobia,phonophobia) frequency
  time frame: At baseline,30 days,and 60 days after treatment
  description: Record of headache aura
  measure: Migraine Disability Assessment
  time frame: At baseline,30 days,and 60 days after treatment
  description: Migraine Disability Assessment (MIDAS)
  measure: Headache Impact
  time frame: At baseline,30 days,and 60 days after treatment
  description: Headache Impact Test (HIT-6)
  measure: Migraine-Specific Questionnaire
  time frame: At baseline,30 days,and 60 days after treatment
  description: Migraine-Specific Questionnaire（MSQ）
  measure: Hospital Anxiety and Depression Scale
  time frame: At baseline,30 days,and 60 days after treatment
  description: Hospital Anxiety and Depression Scale(HADS)
  measure: Patient Clinical Global Impression
  time frame: Patient Clinical Global Impression
  description: At baseline,30 days,and 60 days after treatment(PCGI)
  arm group label: Middle meningeal artery embolization
  arm group type: Experimental
  description: Middle meningeal artery embolization with coil.
  intervention type: Procedure
  intervention name: Middle meningeal artery embolization
  description: Middle meningeal artery embolization with coil.
  arm group label: Middle meningeal artery embolization
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Zeguang Ren, MD. PhD.
  role: Study Chair
  affiliation: The Affiliated Hospital Of Guizhou Medical University
  last name: Zeguang Ren, MD. PhD.
  phone: +8613373419258
  email: renzem@gmail.com
  last name: Junshuan Cui, MD.
  phone: +8615761600325
  email: junshuan2306@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: The Affiliated Hospital Of Guizhou Medical University
  investigator full name: Zeguang Ren
  investigator title: The Affiliated Hospital Of Guizhou Medical University
  mesh term: Migraine Disorders
  sharing ipd: No