IVIG Treatment for Refractory Immune-Related Adult Epilepsy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01545518 |
Recruitment Status
:
Terminated
(Futility criteria, unable for Phase 2 of study, & phase 1 was terminated.)
First Posted
: March 6, 2012
Results First Posted
: September 1, 2014
Last Update Posted
: September 1, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy, Cryptogenic Epilepsy, Partial Seizure Disorder Autoimmune Diseases, Nervous System Limbic Encephalitis | Drug: IVIG | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | IVIG Treatment for Refractory Immune-Related Adult Epilepsy |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
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
|
- Immune Abnormalities [ Time Frame: Screening visit ]neuronal nuclear, cytoplasmic, and cell surface autoantibodies

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545518
United States, Georgia | |
Grady Memorial Hospital | |
Atlanta, Georgia, United States, 30303 | |
The Emory Clinic, Inc. | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Charles M. Epstein, M.D. | Emory University |
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 ( Other Identifier: Other ) |
First Posted: | March 6, 2012 Key Record Dates |
Results First Posted: | September 1, 2014 |
Last Update Posted: | September 1, 2014 |
Last Verified: | August 2014 |
Keywords provided by Charles M. Epstein, MD, Emory University:
Refractory epilepsy Cryptogenic epilepsy Autoimmune disorders |
IVIG Immunomodulatory therapy Autoantibodies |
Additional relevant MeSH terms:
Epilepsy Epilepsies, Partial Seizures Encephalitis Autoimmune Diseases Nervous System Diseases Limbic Encephalitis Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Neurologic Manifestations Signs and Symptoms Immune System Diseases |
Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Neoplasms by Site Neoplasms Paraneoplastic Syndromes Central Nervous System Viral Diseases Central Nervous System Infections Neurodegenerative Diseases Immunoglobulins, Intravenous gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |