Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

NCT ID: NCT03003143

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-09-09

Brief Summary

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Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients

Detailed Description

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Conditions

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Autoimmune Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vigabatrin treatment group

Group Type EXPERIMENTAL

Vigabatrin 500 MG

Intervention Type DRUG

Interventions

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Vigabatrin 500 MG

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kon Chu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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KON CHU, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 18954912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20940040 (View on PubMed)

Other Identifiers

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1607092776

Identifier Type: -

Identifier Source: org_study_id

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