UMIN-CTR Clinical Trial

Public title

'Smoldering' autoimmune inflammatory pathophysiology in epilepsies

Acronym

Autoimmune inflammatory pathophysiology in epilepsies

Scientific Title

'Smoldering' autoimmune inflammatory pathophysiology in epilepsies

Scientific Title:Acronym

Autoimmune inflammatory pathophysiology in epilepsies

Region

Japan

Condition

Epilepsy

Classification by specialty

Neurology

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Anti-neuronal antibodies have been reported in paraneoplastic limbic encephalitis. These antibodies are sometimes positive in patients with partial epilepsy with chronic onset of epilepsy. It is at this moment unclear if these antibodies are related to the etiology of epilepsy.
We made hypotheses as follows:
a. At least in a part of relapsing cases after surgical resection of epileptic foci, relapse could be presumably due to auto-antibodies, which are induced by antigen presentation through blood-brain barrier temporally destructed by surgery. Proepileptogenic zone either adjacent to or remote to the resected foci may be activated by the auto-antibodies.
b. Patients with partial epilepsy with chronic onset of epilepsy without appearent imaging findings suggestive of inflammation may have auto-antibodies. In these patients, 'smoldering' autoimmunity may be contributing to the etiology of epilepsy.
Pathophysiology of these conditions needs to be elucidated with prospective study in order to establish methods of diagnosis and possible immunotherapy. We aim to evaluate the correlation between auto-antibodies and clinical course in patients in the above categories.

Basic objectives2

Others

Basic objectives -Others

Pathophysiology

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Clinical course including auto-antibody titer and other laboratory results, imaging findings and results of neuropsychological tests

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

10

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Non-infectious, so-called smoldering encephalitis cases with medically intractable epilepsy during their chronic course. 2) Patients with partial epilepsy with chronic and elderly onset of epilepsy at times seem cryptogenic. 3) Relapsing cases after surgical resection of epileptic foci. 4) Epileptic patients with amygdalar enlargement with MRI, but without increased glucose metabolism by FDG-PET.

Key exclusion criteria

Patients with dementia

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Akio Ikeda

Organization

Kyoto University School of Medicine

Division name

Department of Neurology

Zip code

Address

54, Shogoin, Sakyo-ku, Kyoto, 606-8508, JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Kyoto University School of Medicine

Division name

Department of Neurology

Zip code

Address

54, Shogoin, Sakyo-ku, Kyoto, 606-8508, JAPAN

TEL

Homepage URL

Email

Institute

Kyoto University School of Medicine

Institute

Department

Personal name

Organization

Japan Society of the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

National Center of Neurology and Psychiatry

Dainippon Sumitomo Pharma

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

01

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2012

Year

01

Month

04

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

In surgical cases, serum and cerebrospinal fluid (CSF) will be obtained and preserved at the time of surgery. In relapsing cases, results of video-electoroencephalography (EEG) monitoring, imaging study, neuropsychological tests and laboratory tests will be evaluated. Auto-antibodies such as anti-NMDAR (N-methyl D-aspartate) and anti-VGKC (voltage-gated potassium channel) -comlex antibodies will be also tested. If autoimmunity is implicated as pathophysiology of relapse, serum and CSF obtained at the time of surgery will be also tested for auto-antibodies, to see trends of titers.

In non-surgical cases, results of video-EEG monitoring, imaging study, neuropsychological tests and laboratory tests will be evaluated. Auto-antibodies such as anti-NMDAR and anti-VGKC-comlex antibodies will be also tested.

If immunotherapy is given due to implication of autoimmune pathophysiology, response to the treatment will be also evaluated.

Registered date

2011

Year

11

Month

30

Day

Last modified on

2012

Year

01

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008039