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Immunotherapy in Intractable Cryptogenic Epilepsy Patients With Autoimmune Antibody

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ClinicalTrials.gov Identifier: NCT02695797
Recruitment Status : Unknown
Verified February 2016 by Sang Kun Lee, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : March 1, 2016
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Sang Kun Lee, Seoul National University Hospital

Brief Summary:
The purpose of the study is to investigate effect of immunotherapy in intractable cryptogenic epilepsy patients with autoimmune antibody.

Condition or disease Intervention/treatment Phase
Epilepsy, Unspecified, Intractable Other: IVIG Drug: Prednisolone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy in Intractable Cryptogenic Epilepsy Patients With Autoimmune Antibody
Study Start Date : September 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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.



Primary Outcome Measures :
  1. Percent seizure reduction [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Seizure free rate [ Time Frame: 3 months ]
  2. Responder rate [ Time Frame: 3 months ]
  3. Treatment failure rate [ Time Frame: 3 months ]
  4. Quality of life scores as measured by QOLIE-31 [ Time Frame: 3 months ]
  5. Quality of life scores as measured by BDI-2 [ Time Frame: 3 months ]
  6. Cognition scores as measured by K-MMSE [ Time Frame: 3 months ]
  7. Amount of epileptiform discharge measured by EEG [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02695797


Contacts
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Contact: Kon Chu, Professor stemcell.snu@gmail.com
Contact: Jung-Ah Lim, Fellow jungah0118@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kon Chu, Professor       stemcell.snu@gmail.com   
Contact: Jung-Ah Lim, Fellow       jungah0118@gmail.com   
Principal Investigator: Sang Kun Lee, Professor         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Sang Kun Lee, Professor Seoul National University Hospital

Publications:

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Responsible Party: Sang Kun Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02695797     History of Changes
Other Study ID Numbers: 1504102666
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sang Kun Lee, Seoul National University Hospital:
Intractable cryptogenic epilepsy with autoimmune antibody
Immunotherapy

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Autoantibodies
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents