Clinical Trial: IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Emory University

Current Primary Outcome: Immune Abnormalities [ Time Frame: Screening visit ]

neuronal nuclear, cytoplasmic, and cell surface autoantibodies


Original Primary Outcome: Decrease in seizure frequency [ Time Frame: Two months following IVIG treatment ]

The primary outcome measure will be a 50% or greater decrease in seizure frequency two months following treatment with IVIG.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Emory University

Dates:
Date Received: November 30, 2011
Date Started: November 2011
Date Completion:
Last Updated: August 21, 2014
Last Verified: August 2014