Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients - A Pilot Study

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03003143

Enrollment

Registered

2016-12-26

Start date

2016-11-30

Completion date

2020-09-09

Last updated

2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Encephalopathy

Brief summary

Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients

Interventions

DRUGVigabatrin 500 MG

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Seizure frequency reduction	3 month of vigabatrin administration	50% reduction - favorable outcome

Secondary

Measure	Time frame
Modified Rankin Scale	3 month of vigabatrin administration
Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31)	after 3 month of vigabatrin administration
Depression (Beck Depression Inventory®-II)	3 month of vigabatrin administration
Cognition (Mini-Mental State Examination-Korean)	3 month of vigabatrin administration
Sleep quality (Pittsburgh Sleep Quality Assessment)	3 month of vigabatrin administration

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026