IVIG Treatment for Refractory Immune-Related Adult Epilepsy
The study is divided into two phases:
Phase I: The investigators will screen for evidence of neuronal nuclear, cytoplasmic, and
cell surface autoantibodies in our population of new onset refractory, imaging-negative
young adult epilepsy patients. This part of the study involves obtaining a single blood
sample, equal to about 2 teaspoons.
Phase 2: If a sufficient number of cases are identified, a double-blind crossover study of
IVIG treatment will be performed in these patients.
Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Decrease in seizure frequency
The primary outcome measure will be a 50% or greater decrease in seizure frequency two months following treatment with IVIG.
Two months following IVIG treatment
Charles M. Epstein, M.D.
United States: Food and Drug Administration
|Grady Memorial Hospital||Atlanta, Georgia 30335|
|The Emory Clinic, Inc.||Atlanta, Georgia 30322|