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/NCT06033846</url>
    </required_header>
    <id_info>
      <org_study_id>XJLL-KY-20232121</org_study_id>
      <nct_id>NCT06033846</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis</brief_title>
    <official_title>Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xijing Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xijing Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Autoimmune encephalitis (AE) is an immune-mediated brain disorder characterized by varied&#xD;
        clinical manifestations that correlate with specific types of antibodies.Typical symptoms&#xD;
        include acute behavioral changes, psychosis, seizures, memory deficits, dyskinesias, speech&#xD;
        impairments, and autonomic and respiratory dysregulation.While the majority of patients&#xD;
        respond well to immunotherapeutic agents, a significant proportion remains resistant to&#xD;
        initial and secondary-line immunotherapies.Minocycline, a semisynthetic tetracycline, is&#xD;
        notably used for the central nervous system due to its lipophilic characteristics and its&#xD;
        capacity to penetrate the blood-brain barrier. While the primary neuroprotective focus of&#xD;
        minocycline in the central nervous system remains unknown, the primary effects of minocycline&#xD;
        include the inhibition of microglial activation, mitigation of apoptosis, and reduction in&#xD;
        reactive oxygen species generation.Protective effect has been observed in hypoxic injury,&#xD;
        ischemic stroke, amyotrophic lateral sclerosis, traumatic spinal cord injury, multiple&#xD;
        sclerosis, Parkinson's disease, and Huntington's disease.Can minocycline offer a protective&#xD;
        role in AE? Consequently, we proposed a randomized, controlled trial to investigate the&#xD;
        efficacy of minocycline in AE.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">May 2028</primary_completion_date>
    <phase>Phase 2</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>MoCA scores</measure>
      <time_frame>3 months</time_frame>
      <description>The proportion of patients with MoCA scores ≥26 at 3 months after enrollment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>mRS scores</measure>
      <time_frame>1 month</time_frame>
      <description>The proportion of patients with mRS scores ≤2 at discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MoCA scores</measure>
      <time_frame>1 month</time_frame>
      <description>The proportion of patients with MoCA scores ≥26 at discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MMSE scores</measure>
      <time_frame>1 month</time_frame>
      <description>The proportion of patients with MMSE scores ≥27 at discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mRS scores</measure>
      <time_frame>at 3 months</time_frame>
      <description>The proportion of patients with mRS scores ≤2 at 3 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MMSE scores</measure>
      <time_frame>at 3 months</time_frame>
      <description>The proportion of patients with MMSE scores ≥27 at 3 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HAMA scores</measure>
      <time_frame>at 3 months</time_frame>
      <description>HAMA scores at 3 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HAMD scores</measure>
      <time_frame>at 3 months</time_frame>
      <description>HAMD scores at 3 months.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>number of participants with medical laboratory results</measure>
      <time_frame>at admission</time_frame>
      <description>medical laboratory results at admission</description>
    </other_outcome>
    <other_outcome>
      <measure>medical imaging data</measure>
      <time_frame>3 months</time_frame>
      <description>medical imaging data at onset</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Autoimmune Encephalitis</condition>
    <arm_group>
      <arm_group_label>Experimental: Treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug: Minocyclin 200 mg oral minocycline for a total of 30 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>first/second-line drugs for autoimmune encephalitis</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Minocycline</intervention_name>
      <description>treatment with minocycline combined with first/second-line drugs for autoimmune encephalitis</description>
      <arm_group_label>Experimental: Treatment group</arm_group_label>
      <other_name>minocycline hydrochloride</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of definite autoimmune encephalitis(Graus et al 2016.)&#xD;
  &#xD;
            2. Age ≥ 18 years&#xD;
  &#xD;
            3. Acute or subacute onset (rapid progression of less than 3 months)&#xD;
  &#xD;
            4. Reasonable exclusion of alternative causes&#xD;
  &#xD;
            5. Written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known allergy to tetracycline antibiotics.&#xD;
  &#xD;
            2. Pregnant women.&#xD;
  &#xD;
            3. Uncontrolled serious concomitant illness.&#xD;
  &#xD;
            4. Known chronic kidney disease stages 3b-5.&#xD;
  &#xD;
            5. Moderate liver disease (see Child-Pugh for Classification of Severity of Liver&#xD;
               Disease).&#xD;
  &#xD;
            6. history of cognitive impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yingchi Zhang</last_name>
      <phone>13228022186</phone>
      <email>zhangyingchi0418@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Xijing Hospital</name>
        <address>
          <city>Xi'an</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yingchi Zhang</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>autoimmune encephalitis</keyword>
    <keyword>minocycline</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Encephalitis</mesh_term>
      <mesh_term>Autoimmune Diseases of the Nervous System</mesh_term>
      <mesh_term>Hashimoto Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Minocycline</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/NCT06033846
  org study id: XJLL-KY-20232121
  nct id: NCT06033846
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Autoimmune encephalitis (AE) is an immune-mediated brain disorder characterized by varied
        clinical manifestations that correlate with specific types of antibodies.Typical symptoms
        include acute behavioral changes, psychosis, seizures, memory deficits, dyskinesias, speech
        impairments, and autonomic and respiratory dysregulation.While the majority of patients
        respond well to immunotherapeutic agents, a significant proportion remains resistant to
        initial and secondary-line immunotherapies.Minocycline, a semisynthetic tetracycline, is
        notably used for the central nervous system due to its lipophilic characteristics and its
        capacity to penetrate the blood-brain barrier. While the primary neuroprotective focus of
        minocycline in the central nervous system remains unknown, the primary effects of minocycline
        include the inhibition of microglial activation, mitigation of apoptosis, and reduction in
        reactive oxygen species generation.Protective effect has been observed in hypoxic injury,
        ischemic stroke, amyotrophic lateral sclerosis, traumatic spinal cord injury, multiple
        sclerosis, Parkinson's disease, and Huntington's disease.Can minocycline offer a protective
        role in AE? Consequently, we proposed a randomized, controlled trial to investigate the
        efficacy of minocycline in AE.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: MoCA scores
  time frame: 3 months
  description: The proportion of patients with MoCA scores ≥26 at 3 months after enrollment.
  measure: mRS scores
  time frame: 1 month
  description: The proportion of patients with mRS scores ≤2 at discharge.
  measure: MoCA scores
  time frame: 1 month
  description: The proportion of patients with MoCA scores ≥26 at discharge.
  measure: MMSE scores
  time frame: 1 month
  description: The proportion of patients with MMSE scores ≥27 at discharge.
  measure: mRS scores
  time frame: at 3 months
  description: The proportion of patients with mRS scores ≤2 at 3 months.
  measure: MMSE scores
  time frame: at 3 months
  description: The proportion of patients with MMSE scores ≥27 at 3 months.
  measure: HAMA scores
  time frame: at 3 months
  description: HAMA scores at 3 months.
  measure: HAMD scores
  time frame: at 3 months
  description: HAMD scores at 3 months.
  measure: number of participants with medical laboratory results
  time frame: at admission
  description: medical laboratory results at admission
  measure: medical imaging data
  time frame: 3 months
  description: medical imaging data at onset
  arm group label: Experimental: Treatment group
  arm group type: Experimental
  description: Drug: Minocyclin 200 mg oral minocycline for a total of 30 days
  arm group label: Control group
  arm group type: No Intervention
  description: first/second-line drugs for autoimmune encephalitis
  intervention type: Drug
  intervention name: Minocycline
  description: treatment with minocycline combined with first/second-line drugs for autoimmune encephalitis
  arm group label: Experimental: Treatment group
  other name: minocycline hydrochloride
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yingchi Zhang
  phone: 13228022186
  email: zhangyingchi0418@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Encephalitis
  mesh term: Autoimmune Diseases of the Nervous System
  mesh term: Hashimoto Disease
  mesh term: Minocycline