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IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Primary Purpose

Epilepsy, Cryptogenic, Epilepsy, Partial, Seizure Disorder

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

IVIG

About this trial

This is an interventional treatment trial for Epilepsy, Cryptogenic focused on measuring Refractory epilepsy, Cryptogenic epilepsy, Autoimmune disorders, IVIG, Immunomodulatory therapy, Autoantibodies

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Grady Memorial Hospital
The Emory Clinic, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all subjects

Arm Description

IVIG

Outcomes

Primary Outcome Measures

Immune Abnormalities

neuronal nuclear, cytoplasmic, and cell surface autoantibodies

Secondary Outcome Measures

Full Information

NCT ID

NCT01545518

First Posted

November 30, 2011

Last Updated

August 21, 2014

Sponsor

Emory University

Collaborators

Baxter Healthcare Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01545518

Brief Title

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Official Title

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Terminated

Why Stopped

Futility criteria, unable for Phase 2 of study, & phase 1 was terminated.

Study Start Date

November 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Cryptogenic, Epilepsy, Partial, Seizure Disorder, Autoimmune Diseases, Nervous System, Limbic Encephalitis

Keywords

Refractory epilepsy, Cryptogenic epilepsy, Autoimmune disorders, IVIG, Immunomodulatory therapy, Autoantibodies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

all subjects

Arm Type

Experimental

Arm Description

IVIG

Intervention Type

Drug

Intervention Name(s)

IVIG

Other Intervention Name(s)

IVIG manufactured by Baxter Healthcare Corporation

Intervention Description

IVIG 2 mg/kg in two divided doses with placebo crossover

Primary Outcome Measure Information:

Title

Immune Abnormalities

Description

neuronal nuclear, cytoplasmic, and cell surface autoantibodies

Time Frame

Screening visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles M. Epstein, M.D.

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Grady Memorial Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

The Emory Clinic, Inc.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

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IVIG Treatment for Refractory Immune-Related Adult Epilepsy

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