IVIG Treatment for Refractory Immune-Related Adult Epilepsy

This study has been terminated.
(Futility criteria, unable for Phase 2 of study, & phase 1 was terminated.)
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Charles M. Epstein, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01545518
First received: November 30, 2011
Last updated: August 21, 2014
Last verified: August 2014
Results First Received: August 21, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Epilepsy, Cryptogenic
Epilepsy, Partial
Seizure Disorder
Autoimmune Diseases, Nervous System
Limbic Encephalitis
Intervention: Drug: IVIG

  Participant Flow
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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
  Description
All Subjects

IVIG

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


Participant Flow:   Overall Study
    All Subjects  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     0  



  Baseline Characteristics
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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
  Description
All Subjects

IVIG

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


Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Gender  
[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
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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
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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
e-mail: cepstei@emory.edu


Publications:


Responsible Party: Charles M. Epstein, MD, Emory University
ClinicalTrials.gov Identifier: NCT01545518     History of Changes
Other Study ID Numbers: IRB00052646, BT11-000312
Study First Received: November 30, 2011
Results First Received: August 21, 2014
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board