Clinical Trial: Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients

Detailed Summary:
Sponsor: Seoul National University Hospital

Current Primary Outcome: Seizure frequency reduction [ Time Frame: 3 month of vigabatrin administration ]

50% reduction - favorable outcome


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: December 13, 2016
Date Started: November 2016
Date Completion:
Last Updated: December 23, 2016
Last Verified: December 2016