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Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

Primary Purpose

Autoimmune Encephalopathy

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vigabatrin 500 MG
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Encephalopathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vigabatrin treatment group

Arm Description

Outcomes

Primary Outcome Measures

Seizure frequency reduction
50% reduction - favorable outcome

Secondary Outcome Measures

Modified Rankin Scale
Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31)
Depression (Beck Depression Inventory®-II)
Cognition (Mini-Mental State Examination-Korean)
Sleep quality (Pittsburgh Sleep Quality Assessment)

Full Information

First Posted
December 13, 2016
Last Updated
September 23, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03003143
Brief Title
Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients
Official Title
Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Study Start Date
November 2016 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
September 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vigabatrin treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vigabatrin 500 MG
Primary Outcome Measure Information:
Title
Seizure frequency reduction
Description
50% reduction - favorable outcome
Time Frame
3 month of vigabatrin administration
Secondary Outcome Measure Information:
Title
Modified Rankin Scale
Time Frame
3 month of vigabatrin administration
Title
Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31)
Time Frame
after 3 month of vigabatrin administration
Title
Depression (Beck Depression Inventory®-II)
Time Frame
3 month of vigabatrin administration
Title
Cognition (Mini-Mental State Examination-Korean)
Time Frame
3 month of vigabatrin administration
Title
Sleep quality (Pittsburgh Sleep Quality Assessment)
Time Frame
3 month of vigabatrin administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KON CHU, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
18954912
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].
Results Reference
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PubMed Identifier
20940040
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.
Results Reference
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Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

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