Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

NCT03003143 — Not applicable, Withdrawn, Seoul National University Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03003143
Status	Withdrawn
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Sponsor	Seoul National University Hospital (Other)
Conditions	Autoimmune Encephalopathy
Interventions	Vigabatrin 500 MG (Drug)
Dates	start 2016-11-01, primary completion 2020-09-09, completion 2020-09-09, first posted 2016-12-26, last updated 2021-09-29
Locations	1 site in South Korea

-Summary

Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Vigabatrin treatment group	Experimental	Drug: Vigabatrin 500 MG

Vigabatrin 500 MG (Drug)

+Outcome measures

Primary outcomes

Seizure frequency reduction [3 month of vigabatrin administration]: 50% reduction - favorable outcome

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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

+Locations (1)

Facility	City	Country	Status
Seoul National University Hospital	Seoul	South Korea

+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. PMID 18954912
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. PMID 20940040

+Investigators

KON CHU, MD, PhD, Study chair, Seoul National University Hospital