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/NCT05987397</url>
    </required_header>
    <id_info>
      <org_study_id>202306124</org_study_id>
      <nct_id>NCT05987397</nct_id>
    </id_info>
    <brief_title>Exploring the Preventive Effect of Mitochondrial Protective Agent Idebenone on Post-stroke Epilepsy</brief_title>
    <official_title>Clinical Multi-center Study of Mitochondrial Brain Protective Agent Idebenone in the Prevention of Post-stroke Epilepsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xiangya Hospital of Central South University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xiangya Hospital of Central South University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        According to the random number table, all patients were divided into short-term treatment&#xD;
        group, long-term treatment group and non-intervention stroke control group according to the&#xD;
        proportion of (1:1:1) epilepsy disease modifier idebenone. Patients in the short-term&#xD;
        treatment group will take idebenone for a total course of 14 days (acute period) after&#xD;
        stroke, and patients in the long-term treatment group will take idebenone for a total course&#xD;
        of 3 months after stroke.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>Phase 4</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>The proportion of patients with epilepsy after stroke</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>Count the number of people with post-stroke epilepsy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The proportion of patients with epilepsy after stroke</measure>
      <time_frame>24 weeks after enrollment</time_frame>
      <description>Count the number of people with post-stroke epilepsy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The proportion of patients with epilepsy after stroke</measure>
      <time_frame>48 weeks after enrollment</time_frame>
      <description>Count the number of people with post-stroke epilepsy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>National Institutes of Health Stroke Scale (NIHSS)</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>National Institutes of Health Stroke Scale (NIHSS)</measure>
      <time_frame>24 weeks after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>National Institutes of Health Stroke Scale (NIHSS)</measure>
      <time_frame>48 weeks after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Anxiety Scale (HAMA)</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Anxiety Scale (HAMA)</measure>
      <time_frame>24 weeks after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Anxiety Scale (HAMA)</measure>
      <time_frame>48 weeks after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Depression Scale (HAMD)</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Depression Scale (HAMD)</measure>
      <time_frame>24 weeks after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Depression Scale (HAMD)</measure>
      <time_frame>48 weeks after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh sleep quality index (PSQI)</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh sleep quality index (PSQI)</measure>
      <time_frame>24 weeks after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh sleep quality index (PSQI)</measure>
      <time_frame>48 weeks after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke specific quality of life scale (SS-QOL)</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke specific quality of life scale (SS-QOL)</measure>
      <time_frame>24 weeks after enrollment</time_frame>
      <description>The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke specific quality of life scale (SS-QOL)</measure>
      <time_frame>48 weeks after enrollment</time_frame>
      <description>The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2700</enrollment>
    <condition>Post Stroke Epilepsy</condition>
    <arm_group>
      <arm_group_label>Group A: Idebenone short-term treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B: Idebenone long-term treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>idebenone 30 mg for 14 days</intervention_name>
      <description>The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase).</description>
      <arm_group_label>Group A: Idebenone short-term treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>idebenone 30 mg for 3 months</intervention_name>
      <description>The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.</description>
      <arm_group_label>Group B: Idebenone long-term treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients admitted to hospital within 24 hours of stroke symptoms and diagnosed with&#xD;
               stroke (including cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage,&#xD;
               intracranial venous sinus thrombosis, etc.) after relevant examinations;&#xD;
  &#xD;
            -  Able to cooperate with the inspection;&#xD;
  &#xD;
            -  Sign the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of epilepsy before stroke;&#xD;
  &#xD;
            -  A history of serious comorbidities that may lead to seizures (including malignant&#xD;
               tumors, specific autoimmune diseases, severe electrolyte abnormalities, end-stage&#xD;
               renal disease, and severe head trauma);&#xD;
  &#xD;
            -  Secondary stroke caused by head trauma or surgery;&#xD;
  &#xD;
            -  Other patients that the researchers think need to be excluded.&#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_contact>
      <last_name>Li Feng, PhD</last_name>
      <phone>86-13873123853</phone>
      <email>fenglihx@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Xiangya Hospital, Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410008</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Li Feng, PhD</last_name>
        <phone>86-13873123853</phone>
        <email>fenglihx@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Xiangya Hospital of Central South University</investigator_affiliation>
      <investigator_full_name>Li Feng, MD, PhD</investigator_full_name>
      <investigator_title>Associate Professor Vice Director of Neurology Teaching and Research Office</investigator_title>
    </responsible_party>
    <keyword>post-stroke epilepsy</keyword>
    <keyword>idebenone</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Epilepsy</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ubiquinone</mesh_term>
      <mesh_term>Idebenone</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05987397
  org study id: 202306124
  nct id: NCT05987397
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  According to the random number table, all patients were divided into short-term treatment
        group, long-term treatment group and non-intervention stroke control group according to the
        proportion of (1:1:1) epilepsy disease modifier idebenone. Patients in the short-term
        treatment group will take idebenone for a total course of 14 days (acute period) after
        stroke, and patients in the long-term treatment group will take idebenone for a total course
        of 3 months after stroke.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The proportion of patients with epilepsy after stroke
  time frame: At the time of enrollment
  description: Count the number of people with post-stroke epilepsy
  measure: The proportion of patients with epilepsy after stroke
  time frame: 24 weeks after enrollment
  description: Count the number of people with post-stroke epilepsy
  measure: The proportion of patients with epilepsy after stroke
  time frame: 48 weeks after enrollment
  description: Count the number of people with post-stroke epilepsy
  measure: National Institutes of Health Stroke Scale (NIHSS)
  time frame: At the time of enrollment
  description: The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients
  measure: National Institutes of Health Stroke Scale (NIHSS)
  time frame: 24 weeks after enrollment
  description: The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients
  measure: National Institutes of Health Stroke Scale (NIHSS)
  time frame: 48 weeks after enrollment
  description: The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients
  measure: Hamilton Anxiety Scale (HAMA)
  time frame: At the time of enrollment
  description: The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
  measure: Hamilton Anxiety Scale (HAMA)
  time frame: 24 weeks after enrollment
  description: The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
  measure: Hamilton Anxiety Scale (HAMA)
  time frame: 48 weeks after enrollment
  description: The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
  measure: Hamilton Depression Scale (HAMD)
  time frame: At the time of enrollment
  description: The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
  measure: Hamilton Depression Scale (HAMD)
  time frame: 24 weeks after enrollment
  description: The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
  measure: Hamilton Depression Scale (HAMD)
  time frame: 48 weeks after enrollment
  description: The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
  measure: Pittsburgh sleep quality index (PSQI)
  time frame: At the time of enrollment
  description: The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
  measure: Pittsburgh sleep quality index (PSQI)
  time frame: 24 weeks after enrollment
  description: The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
  measure: Pittsburgh sleep quality index (PSQI)
  time frame: 48 weeks after enrollment
  description: The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
  measure: Stroke specific quality of life scale (SS-QOL)
  time frame: At the time of enrollment
  description: The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
  measure: Stroke specific quality of life scale (SS-QOL)
  time frame: 24 weeks after enrollment
  description: The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
  measure: Stroke specific quality of life scale (SS-QOL)
  time frame: 48 weeks after enrollment
  description: The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
  arm group label: Group A: Idebenone short-term treatment group
  arm group type: Experimental
  description: The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase).
  arm group label: Group B: Idebenone long-term treatment group
  arm group type: Experimental
  description: The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.
  intervention type: Drug
  intervention name: idebenone 30 mg for 14 days
  description: The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase).
  arm group label: Group A: Idebenone short-term treatment group
  intervention type: Drug
  intervention name: idebenone 30 mg for 3 months
  description: The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.
  arm group label: Group B: Idebenone long-term treatment group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Li Feng, PhD
  phone: 86-13873123853
  email: fenglihx@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Xiangya Hospital of Central South University
  investigator full name: Li Feng, MD, PhD
  investigator title: Associate Professor Vice Director of Neurology Teaching and Research Office
  mesh term: Stroke
  mesh term: Epilepsy
  mesh term: Ubiquinone
  mesh term: Idebenone