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Trial record 9 of 14 for:    Autoimmune encephalitis

Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

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ClinicalTrials.gov Identifier: NCT03003143
Recruitment Status : Unknown
Verified October 2017 by Kon Chu, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : December 26, 2016
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Kon Chu, Seoul National University Hospital

Brief Summary:
Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients

Condition or disease Intervention/treatment Phase
Autoimmune Encephalopathy Drug: Vigabatrin 500 MG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients - A Pilot Study
Study Start Date : November 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
Drug Information available for: Vigabatrin

Arm Intervention/treatment
Experimental: Vigabatrin treatment group Drug: Vigabatrin 500 MG



Primary Outcome Measures :
  1. Seizure frequency reduction [ Time Frame: 3 month of vigabatrin administration ]
    50% reduction - favorable outcome


Secondary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 3 month of vigabatrin administration ]
  2. Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31) [ Time Frame: after 3 month of vigabatrin administration ]
  3. Depression (Beck Depression Inventory®-II) [ Time Frame: 3 month of vigabatrin administration ]
  4. Cognition (Mini-Mental State Examination-Korean) [ Time Frame: 3 month of vigabatrin administration ]
  5. Sleep quality (Pittsburgh Sleep Quality Assessment) [ Time Frame: 3 month of vigabatrin administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-85
  • Possible autoimmune encephalitis
  • Patients who have been diagnosed and treated for encephalitis for more than 4 weeks
  • Patients with epilepsy (EEG finding or clinically)

Exclusion Criteria:

  • septic shock, fever >38.5 ℃, O2 saturation <90%, respiratory rate >25, HR >120
  • previously, mRS=3 or mRS>3
  • MMSE<20
  • Patients who have terminal disease
  • eye problem
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003143


Contacts
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Contact: KON CHU, MD, PhD 82-2-2072-3192 stemcell.snu@gmail.com
Contact: JIN-SUN JUN, MD 82-2-2072-3192 junjinsun0401@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kon Chu, Professor       stemcell.snu@gmail.com   
Contact: JIN-SUN JUN, Fellow       junjinsun0401@gmail.com   
Principal Investigator: Kon Chu, MD, PhD.         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: KON CHU, MD, PhD Seoul National University Hospital

Publications:
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Responsible Party: Kon Chu, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03003143     History of Changes
Other Study ID Numbers: 1607092776
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vigabatrin
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs