Immunotherapy in Intractable Cryptogenic Epilepsy Patients With Autoimmune Antibody

February 29, 2016 updated by: Sang Kun Lee, Seoul National University Hospital
The purpose of the study is to investigate effect of immunotherapy in intractable cryptogenic epilepsy patients with autoimmune antibody.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cryptogenic epilepsy is an epilepsy of presumed symptomatic nature but the cause has not been identified. It account for at least 40% of adult-onset epilepsy. Autoimmune encephalitis including classic paraneoplastic syndrome and autoimmune synaptic encephalitis is a new category of immune-mediated disorders which often has favorable outcome. Recent studies reported that immunotherapy improves seizure outcome in medically intractable epilepsy patients with clinical and serological evidence of an autoimmune basis. Neural autoantibodies were detected in 22% of epilepsy due to unknown cause in a study, mostly from the antiepileptic drug(AED)-resistant epilepsy group. Of the patients who received immunotherapy, 75% archived >50% reduction in seizure frequency.

Many patients with cryptogenic epilepsy are refractory to AED and significant percent of cryptogenic epilepsy harbor neural autoantibody. In those cases, immunotherapy is suggestive based on favorable outcome of immunotherapy in autoimmune encephalitis and autoimmune epilepsy. Investigators aim to investigate the response to immunotherapy in intractable cryptogenic epilepsy patients with neural autoantibodies.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A diagnosis of cryptogenic epilepsy according to the International League Against Epilepsy's Classification of Epilepsy.
  • Intractable epilepsy: Complete seizure control is not achieved with trials of two appropriate antiepileptic drugs
  • At least 1 seizure within the past 8 weeks
  • Presence of autoimmune antibody (NMDAR, LGI1, CASPR2, AMPA1, AMPA2, GABAB-R, anti-Hu, -Yo, -Ri, -Ma2, -CV2/CRMP5, -amphiphysin, GAD) in serum or cerebrospinal fluid
  • Written informed consent signed by the subject or legal guardian prior to entering the study

Exclusion Criteria:

  • Clinical evidence of autoimmune encephalitis such as autoimmune limbic encephalitis
  • History of severe head trauma
  • Presence of structural abnormality which is thought to be epileptogenic in brain MRI
  • Epilepsy of predominantly genetic or presumed genetic origin
  • An active CNS infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results History of immunotherapy
  • A history of nonepileptic or psychogenic seizures within past 1 year
  • Any clinically significant laboratory abnormality that in the opinion of the Investigator would exclude the subject from the study
  • Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the Investigator, would interfere with the subject's ability to participate in the study
  • Recent (within 4 weeks) change or dose adjustment of anti-epileptic drug (1 to 2 doses of rescue benzodiazepine is permitted)
  • Refuse to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunotherapy
Intravenous immunoglobulin (IVIG) and oral prednisolone. IVIG and oral prednisolone are administered simultaneously: IVIG (400mg/kg/day for 5 days) with oral prednisolone (60mg for 5days, than decrease by 10 mg every 2 day).
Other: IVIG
IVIG (400mg/kg/day for 5 days) with oral prednisolone (60mg for 5days, than decrease by 10 mg every 2 day)
Drug: Prednisolone
IVIG (400mg/kg/day for 5 days) with oral prednisolone (60mg for 5days, than decrease by 10 mg every 2 day)
No Intervention: Control
No immunotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent seizure reduction
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Seizure free rate
Time Frame: 3 months
3 months
Responder rate
Time Frame: 3 months
3 months
Treatment failure rate
Time Frame: 3 months
3 months
Quality of life scores as measured by QOLIE-31
Time Frame: 3 months
3 months
Quality of life scores as measured by BDI-2
Time Frame: 3 months
3 months
Cognition scores as measured by K-MMSE
Time Frame: 3 months
3 months
Amount of epileptiform discharge measured by EEG
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Sang Kun Lee, Professor, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1504102666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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