IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Last updated: August 21, 2014
Sponsor: Emory University
Overall Status: Terminated

Phase

2

Condition

Epilepsy

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

N/A

Clinical Study ID

NCT01545518
IRB00052646
BT11-000312
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of uncontrolled epilepsy with at least two seizures a month for threeconsecutive months.

  • Age 18 to 50.

  • Clinical semiology or electroencephalogram (EEG) consistent with partial onsetepilepsy.

  • 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 theexception of hippocampal sclerosis

Exclusion

Exclusion Criteria:

  • History of severe prematurity or neonatal distress, febrile seizures, moderate orsever 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.

Study Design

Total Participants: 20
Study Start date:
November 01, 2011
Estimated Completion Date:
August 31, 2013

Study 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.

Connect with a study center

  • Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • The Emory Clinic, Inc.

    Atlanta, Georgia 30322
    United States

    Site Not Available

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