IVIG Treatment for Refractory Immune-Related Adult Epilepsy
The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG).
The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG.
At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.
Autoimmune Diseases, Nervous System
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||IVIG Treatment for Refractory Immune-Related Adult Epilepsy|
- Decrease in seizure frequency [ Time Frame: Two months following IVIG treatment ] [ Designated as safety issue: No ]The primary outcome measure will be a 50% or greater decrease in seizure frequency two months following treatment with IVIG.
|Study Start Date:||November 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: all subjects
IVIG 2 mg/kg in two divided doses with placebo crossover
Other Name: IVIG manufactured by Baxter Healthcare Corporation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545518
|United States, Georgia|
|The Emory Clinic, Inc.|
|Atlanta, Georgia, United States, 30322|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Charles M. Epstein, M.D.||Emory University|