IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Phase 2

Terminated

• Conditions: Epilepsy, Cryptogenic; Epilepsy, Partial; Limbic Encephalitis; Seizure Disorder; Autoimmune Diseases, Nervous System
• Interventions: Drug: IVIG

• Registration Number: NCT01545518
• Lead Sponsor: Emory University

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 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-06
• Primary Completion: 2013-06
• Study Completion: 2013-08
• Status Verified: 2014-08
• Results First Submitted: 2014-08-21
• Results First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Results First Posted: 2014-09-01
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of uncontrolled epilepsy with at least two seizures a month for three consecutive months.
• Age 18 to 50.
• Clinical semiology or electroencephalogram (EEG) consistent with partial onset epilepsy.
• Refractory to an adequate trial of two or more main-line anti-epileptic drugs.
• Ability to keep a seizure diary.
• Normal brain magnetic resonance imaging (MRI) - 3 Tesla, seizure protocol; with the exception of hippocampal sclerosis

Read More

Exclusion Criteria

• History of severe prematurity or neonatal distress, febrile seizures, moderate or sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis, neurocutaneous syndromes, or intracranial metal objects.
• Evidence of psychogenic epilepsy.
• History of convulsive status epilepticus.
• History of primary generalized epilepsy in a first degree relative.
• Known serious medical illness.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
all subjects	IVIG	IVIG

Primary Outcome Measures

Name	Time	Method
Immune Abnormalities	Screening visit	neuronal nuclear, cytoplasmic, and cell surface autoantibodies

Trial Locations

Locations (2)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

The Emory Clinic, Inc.; 🇺🇸 Atlanta, Georgia, United States