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Immunologic Factors

IVIG 2 mg/kg in two divided doses with placebo crossover

IVIG

Charles M. Epstein, M.D.

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.

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.

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

neuronal nuclear, cytoplasmic, and cell surface autoantibodies

Baxter Healthcare Corporation

Emory University

Professsor of Neurology - Divsion of Epilepsy

IVIG

IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover

No AE's.

All Subjects

IVIG

IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Study was terminated early. Subject eligibility for phase 2 not available.

Dr. Charles M. Epstein

No analysis occurred and study was terminated early due to subject numbers not eligible for the 2nd phase of the study.

Immune Abnormalities

Overall Study

Spots Global Cancer Trial Database for epilepsy, partial