IVIG Treatment for Refractory Immune-Related Adult Epilepsy

This study has been terminated.
(Futility criteria, unable for Phase 2 of study, & phase 1 was terminated.)
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: August 21, 2014
Last verified: August 2014
  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: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Immune Abnormalities [ Time Frame: Screening visit ] [ Designated as safety issue: No ]
    neuronal nuclear, cytoplasmic, and cell surface autoantibodies


Enrollment: 20
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: all subjects
IVIG
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: IRB00052646, BT11-000312
Study First Received: November 30, 2011
Results First Received: August 21, 2014
Last Updated: August 21, 2014
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:
Autoimmune Diseases
Encephalitis
Epilepsy
Epilepsies, Partial
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 September 11, 2014