IVIG Treatment for Refractory Immune-Related Adult Epilepsy
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|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
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)|
|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|
Experimental: all subjects
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
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|