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IVIG Treatment for Refractory Immune-Related Adult Epilepsy

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ClinicalTrials.gov Identifier: NCT01545518
Recruitment Status : Terminated (Futility criteria, unable for Phase 2 of study, & phase 1 was terminated.)
First Posted : March 6, 2012
Results First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Charles M. Epstein, MD, 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.

Condition or disease Intervention/treatment Phase
Epilepsy, Cryptogenic Epilepsy, Partial Seizure Disorder Autoimmune Diseases, Nervous System Limbic Encephalitis Drug: IVIG Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: IVIG Treatment for Refractory Immune-Related Adult Epilepsy
Study Start Date : November 2011
Primary Completion Date : June 2013
Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: all subjects
Drug: IVIG
IVIG 2 mg/kg in two divided doses with placebo crossover
Other Name: IVIG manufactured by Baxter Healthcare Corporation

Primary Outcome Measures :
  1. Immune Abnormalities [ Time Frame: Screening visit ]
    neuronal nuclear, cytoplasmic, and cell surface autoantibodies

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545518

United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
The Emory Clinic, Inc.
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Baxter Healthcare Corporation
Principal Investigator: Charles M. Epstein, M.D. Emory University


Responsible Party: Charles M. Epstein, MD, Professsor of Neurology - Divsion of Epilepsy, Emory University
ClinicalTrials.gov Identifier: NCT01545518     History of Changes
Other Study ID Numbers: IRB00052646
BT11-000312 ( Other Identifier: Other )
First Posted: March 6, 2012    Key Record Dates
Results First Posted: September 1, 2014
Last Update Posted: September 1, 2014
Last Verified: August 2014

Keywords provided by Charles M. Epstein, MD, Emory University:
Refractory epilepsy
Cryptogenic epilepsy
Autoimmune disorders
Immunomodulatory therapy

Additional relevant MeSH terms:
Epilepsies, Partial
Autoimmune Diseases
Nervous System Diseases
Limbic Encephalitis
Autoimmune Diseases of the Nervous System
Brain Diseases
Central Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Immune System Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Paraneoplastic Syndromes
Central Nervous System Viral Diseases
Central Nervous System Infections
Neurodegenerative Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs