Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

Autoimmune Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03003143
• Other study ID #: 1607092776
• Status: Withdrawn
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 9, 2020

Study information

• Verified date: September 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Encephalopathy
• Brain Diseases
• Encephalitis

Intervention

Drug:
• Vigabatrin 500 MG

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Bjurstöm 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]. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure frequency reduction	50% reduction - favorable outcome	3 month of vigabatrin administration
Secondary	Modified Rankin Scale		3 month of vigabatrin administration
Secondary	Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31)		after 3 month of vigabatrin administration
Secondary	Depression (Beck Depression Inventory®-II)		3 month of vigabatrin administration
Secondary	Cognition (Mini-Mental State Examination-Korean)		3 month of vigabatrin administration
Secondary	Sleep quality (Pittsburgh Sleep Quality Assessment)		3 month of vigabatrin administration