UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006800
Receipt No. R000008039
Scientific Title 'Smoldering' autoimmune inflammatory pathophysiology in epilepsies
Date of disclosure of the study information 2012/01/04
Last modified on 2012/01/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition Epilepsy
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Clinical course including auto-antibody titer and other laboratory results, imaging findings and results of neuropsychological tests
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kyoto University School of Medicine
Institute
Department

Funding Source
Organization Japan Society of the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) National Center of Neurology and Psychiatry

Dainippon Sumitomo Pharma

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
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.

Management information
Registered date
2011 Year 11 Month 30 Day
Last modified on
2012 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008039

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.