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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

November 30, 2011
August 21, 2014
November 2011
June 2013   (final data collection date for primary outcome measure)
Immune Abnormalities [ Time Frame: Screening visit ] [ Designated as safety issue: No ]
neuronal nuclear, cytoplasmic, and cell surface autoantibodies
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.
Complete list of historical versions of study NCT01545518 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
IVIG Treatment for Refractory Immune-Related Adult Epilepsy
IVIG Treatment for Refractory Immune-Related Adult Epilepsy

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Epilepsy, Cryptogenic
  • Epilepsy, Partial
  • Seizure Disorder
  • Autoimmune Diseases, Nervous System
  • Limbic Encephalitis
Drug: IVIG
IVIG 2 mg/kg in two divided doses with placebo crossover
Other Name: IVIG manufactured by Baxter Healthcare Corporation
Experimental: all subjects
IVIG
Intervention: Drug: IVIG

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
August 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01545518
IRB00052646, BT11-000312
No
Charles M. Epstein, MD, Emory University
Emory University
Baxter Healthcare Corporation
Principal Investigator: Charles M. Epstein, M.D. Emory University
Emory University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP