Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients
- Registration Number
- NCT03003143
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vigabatrin treatment group Vigabatrin 500 MG -
- Primary Outcome Measures
Name Time Method Seizure frequency reduction 3 month of vigabatrin administration 50% reduction - favorable outcome
- Secondary Outcome Measures
Name Time Method Modified Rankin Scale 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 Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31) after 3 month of vigabatrin administration Sleep quality (Pittsburgh Sleep Quality Assessment) 3 month of vigabatrin administration
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of