Clinical trial NCT01545518: IVIG Treatment for Refractory Immune-Related Adult Epilepsy
Official title: IVIG Treatment for Refractory Immune-Related Adult Epilepsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Epilepsy, Cryptogenic
Epilepsy, Partial
Seizure Disorder
Autoimmune Diseases, Nervous System
Limbic Encephalitis
Keywords: Refractory epilepsy
Cryptogenic epilepsy
Autoimmune disorders
IVIG
Immunomodulatory therapy
Autoantibodies
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2012-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Immune Abnormalities
timeFrame: Screening visit
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic, Inc.
state: Georgia
Study officials:
affiliation: Emory University
name: Charles M. Epstein, M.D.
role: PRINCIPAL_INVESTIGATOR
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