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. 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
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Charles M. Epstein, MD, Emory University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Epilepsy, Cryptogenic
Epilepsy, Partial
Seizure Disorder
Autoimmune Diseases, Nervous System
Limbic Encephalitis
Intervention: Drug: IVIG

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled in a medical setting if eligible. Inclusion and exclusion criteria. A total of 20 patients with unexplained refractory epilepsy were screened and tested with a multiple panel for anti-neuronal antibodies.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In comparisons with our original futility criteria, it was apparent that the absence of more powerful findings, and the time it took to collect the ones we have, indicated the virtual impossibility of identifying enough patients with strong autoimmune findings to carry out Phase 2 of this study.

Reporting Groups
All Subjects


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

Participant Flow:   Overall Study
    All Subjects

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
18-50 years of age, both male and female

Reporting Groups
All Subjects


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

Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   20 
>=65 years   0 
[Units: Participants]
Female   11 
Male   9 
Region of Enrollment 
[Units: Participants]
United States   20 

  Outcome Measures

1.  Primary:   Immune Abnormalities   [ Time Frame: Screening visit ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated early. Subject eligibility for phase 2 not available.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Charles M. Epstein
Organization: Emory University
phone: 404-778-3633


Responsible Party: Charles M. Epstein, MD, Emory University Identifier: NCT01545518     History of Changes
Other Study ID Numbers: IRB00052646
BT11-000312 ( Other Identifier: Other )
First Submitted: November 30, 2011
First Posted: March 6, 2012
Results First Submitted: August 21, 2014
Results First Posted: September 1, 2014
Last Update Posted: September 1, 2014