<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/NCT03003143</url>
  </required_header>
  <id_info>
    <org_study_id>1607092776</org_study_id>
    <nct_id>NCT03003143</nct_id>
  </id_info>
  <brief_title>Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients</brief_title>
  <official_title>Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">September 9, 2020</completion_date>
  <primary_completion_date type="Actual">September 9, 2020</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>Seizure frequency reduction</measure>
    <time_frame>3 month of vigabatrin administration</time_frame>
    <description>50% reduction - favorable outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>3 month of vigabatrin administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31)</measure>
    <time_frame>after 3 month of vigabatrin administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression (Beck Depression Inventory®-II)</measure>
    <time_frame>3 month of vigabatrin administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition (Mini-Mental State Examination-Korean)</measure>
    <time_frame>3 month of vigabatrin administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality (Pittsburgh Sleep Quality Assessment)</measure>
    <time_frame>3 month of vigabatrin administration</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Autoimmune Encephalopathy</condition>
  <arm_group>
    <arm_group_label>Vigabatrin treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vigabatrin 500 MG</intervention_name>
    <arm_group_label>Vigabatrin treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-85&#xD;
&#xD;
          -  Possible autoimmune encephalitis&#xD;
&#xD;
          -  Patients who have been diagnosed and treated for encephalitis for more than 4 weeks&#xD;
&#xD;
          -  Patients with epilepsy (EEG finding or clinically)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  septic shock, fever &gt;38.5 ℃, O2 saturation &lt;90%, respiratory rate &gt;25, HR &gt;120&#xD;
&#xD;
          -  previously, mRS=3 or mRS&gt;3&#xD;
&#xD;
          -  MMSE&lt;20&#xD;
&#xD;
          -  Patients who have terminal disease&#xD;
&#xD;
          -  eye problem&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KON CHU, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Bjurstom H, Wang J, Ericsson I, Bengtsson M, Liu Y, Kumar-Mendu S, Issazadeh-Navikas S, Birnir B. GABA, a natural immunomodulator of T lymphocytes. J Neuroimmunol. 2008 Dec 15;205(1-2):44-50. doi: 10.1016/j.jneuroim.2008.08.017. Epub 2008 Oct 26. Erratum In: J Neuroimmunol. 2009 Sep 29;214(1-2):133. Wang, Junyang [corrected to Wang, JunYang].</citation>
    <PMID>18954912</PMID>
  </reference>
  <reference>
    <citation>Rossi S, Muzio L, De Chiara V, Grasselli G, Musella A, Musumeci G, Mandolesi G, De Ceglia R, Maida S, Biffi E, Pedrocchi A, Menegon A, Bernardi G, Furlan R, Martino G, Centonze D. Impaired striatal GABA transmission in experimental autoimmune encephalomyelitis. Brain Behav Immun. 2011 Jul;25(5):947-56. doi: 10.1016/j.bbi.2010.10.004. Epub 2010 Oct 20.</citation>
    <PMID>20940040</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Kon Chu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Encephalitis</mesh_term>
    <mesh_term>Autoimmune Diseases of the Nervous System</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vigabatrin</mesh_term>
  </intervention_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/NCT03003143
org study id: 1607092776
nct id: NCT03003143
lead sponsor: 
Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Seizure frequency reduction
time frame: 3 month of vigabatrin administration
description: 50% reduction - favorable outcome
measure: Modified Rankin Scale
time frame: 3 month of vigabatrin administration
measure: Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31)
time frame: after 3 month of vigabatrin administration
measure: Depression (Beck Depression Inventory®-II)
time frame: 3 month of vigabatrin administration
measure: Cognition (Mini-Mental State Examination-Korean)
time frame: 3 month of vigabatrin administration
measure: Sleep quality (Pittsburgh Sleep Quality Assessment)
time frame: 3 month of vigabatrin administration
arm group label: Vigabatrin treatment group
arm group type: Experimental
intervention type: Drug
intervention name: Vigabatrin 500 MG
arm group label: Vigabatrin treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: KON CHU, MD, PhD
role: Study Chair
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Bjurstom H, Wang J, Ericsson I, Bengtsson M, Liu Y, Kumar-Mendu S, Issazadeh-Navikas S, Birnir B. GABA, a natural immunomodulator of T lymphocytes. J Neuroimmunol. 2008 Dec 15;205(1-2):44-50. doi: 10.1016/j.jneuroim.2008.08.017. Epub 2008 Oct 26. Erratum In: J Neuroimmunol. 2009 Sep 29;214(1-2):133. Wang, Junyang [corrected to Wang, JunYang].
PMID: 18954912
citation: Rossi S, Muzio L, De Chiara V, Grasselli G, Musella A, Musumeci G, Mandolesi G, De Ceglia R, Maida S, Biffi E, Pedrocchi A, Menegon A, Bernardi G, Furlan R, Martino G, Centonze D. Impaired striatal GABA transmission in experimental autoimmune encephalomyelitis. Brain Behav Immun. 2011 Jul;25(5):947-56. doi: 10.1016/j.bbi.2010.10.004. Epub 2010 Oct 20.
PMID: 20940040
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Kon Chu
investigator title: Professor
mesh term: Brain Diseases
mesh term: Encephalitis
mesh term: Autoimmune Diseases of the Nervous System
mesh term: Vigabatrin