Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

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

Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients

Study Overview

• Status: Withdrawn
• Conditions: Autoimmune Encephalopathy
• Intervention / Treatment: Drug: Vigabatrin 500 MG

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vigabatrin treatment group	Drug: Vigabatrin 500 MG

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: KON CHU, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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].
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): September 9, 2020
• Study Completion (Actual): September 9, 2020

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Encephalitis; Brain Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; GABA Agents; Anticonvulsants; Vigabatrin
• Other Study ID Numbers: 1607092776