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IVIG Treatment for Refractory Immune-Related Adult Epilepsy


Phase 2
18 Years
50 Years
Open (Enrolling by invite only)
Both
Epilepsy, Cryptogenic, Epilepsy, Partial, Seizure Disorder, Autoimmune Diseases, Nervous System, Limbic Encephalitis

Thank you

Trial Information

IVIG Treatment for Refractory Immune-Related Adult Epilepsy


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Decrease in seizure frequency

Outcome Description:

The primary outcome measure will be a 50% or greater decrease in seizure frequency two months following treatment with IVIG.

Outcome Time Frame:

Two months following IVIG treatment

Safety Issue:

No

Principal Investigator

Charles M. Epstein, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University

Authority:

United States: Food and Drug Administration

Study ID:

BT11-000312

NCT ID:

NCT01545518

Start Date:

November 2011

Completion Date:

November 2013

Related Keywords:

  • Epilepsy, Cryptogenic
  • Epilepsy, Partial
  • Seizure Disorder
  • Autoimmune Diseases, Nervous System
  • Limbic Encephalitis
  • Refractory epilepsy
  • Cryptogenic epilepsy
  • Autoimmune disorders
  • IVIG
  • Immunomodulatory therapy
  • Autoantibodies
  • Autoimmune Diseases
  • Encephalitis
  • Epilepsy
  • Epilepsies, Partial
  • Nervous System Diseases
  • Seizures
  • Limbic Encephalitis
  • Autoimmune Diseases of the Nervous System

Name

Location
Grady Memorial Hospital Atlanta, Georgia  30335
The Emory Clinic, Inc. Atlanta, Georgia  30322