IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Seizure Disorder Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoimmune Diseases of the Nervous System
• Autoimmune Diseases, Nervous System
• Encephalitis
• Epilepsies, Partial
• Epilepsy
• Epilepsy, Cryptogenic
• Epilepsy, Partial
• Limbic Encephalitis
• Nervous System Diseases
• Seizure Disorder

• NCT number: NCT01545518
• Study type: Interventional
• Source: Emory University
• Status: Terminated
• Phase: Phase 2
• Start date: November 2011
• Completion date: August 2013