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IVIG Treatment for Refractory Immune-Related Adult Epilepsy

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Charles M. Epstein, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01545518
First received: November 30, 2011
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Epilepsy, Cryptogenic
Epilepsy, Partial
Seizure Disorder
Autoimmune Diseases, Nervous System
Limbic Encephalitis
 Drug: IVIG
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Decrease in seizure frequency [ Time Frame: Two months following IVIG treatment ] [ Designated as safety issue: No ]
    The primary outcome measure will be a 50% or greater decrease in seizure frequency two months following treatment with IVIG.


Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: all subjects Drug: IVIG
IVIG 2 mg/kg in two divided doses with placebo crossover
Other Name: IVIG manufactured by Baxter Healthcare Corporation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545518

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

Publications:

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: BT11-000312
Study First Received: November 30, 2011
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Emory University:
Refractory epilepsy
Cryptogenic epilepsy
Autoimmune disorders
 IVIG
Immunomodulatory therapy
Autoantibodies

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Autoimmune Diseases
Encephalitis
Nervous System Diseases
Seizures
Limbic Encephalitis
Autoimmune Diseases of the Nervous System
Immune System Diseases
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
 Central Nervous System Infections
Neurologic Manifestations
Signs and Symptoms
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013