UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004120
Receipt number R000004954
Scientific Title Far East Asian Survey for Catastrophic Epilepsy in infancy and early childhood
Date of disclosure of the study information 2010/08/28
Last modified on 2010/08/28 19:08:07

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Basic information

Public title

Far East Asian Survey for Catastrophic Epilepsy in infancy and early childhood

Acronym

FACE study

Scientific Title

Far East Asian Survey for Catastrophic Epilepsy in infancy and early childhood

Scientific Title:Acronym

FACE study

Region

Japan Asia(except Japan)


Condition

Condition

epilepsy

Classification by specialty

Neurology Pediatrics Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate etiology, clinical features, treatment modalities and long-term prognosis of seizure and development in catastrophic epilepsy patients in infancy and early childhood and clarify the prognostic factors comparing treatment modalities in order to identify surgical candidates effectively.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

seizure prognosis

Key secondary outcomes

developmental prognosis


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

0 years-old <=

Age-upper limit

5 years-old >=

Gender

Male and Female

Key inclusion criteria

Children with intractable epilepsies under 6 years old on admission between 2009/04/01 to 2010/03/31.

Key exclusion criteria

1) non-epileptic condition
2) benign epilepsy
3) sever systemic complications, sever systemic congenital and/or genetic anomalies
4) previous epilepsy surgery

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Taisuke OTSUKI

Organization

National Center of Neurology and Psychiatry

Division name

Department of Neurosurgery

Zip code


Address

Ogawahigashi-4-1-1, Kodaira, Tokyo, Japan

TEL

+81-42-341-2711

Email



Public contact

Name of contact person

1st name
Middle name
Last name Taisuke OTSUKI

Organization

National Center of Neurology and Psychiatry

Division name

Department of Neurosurgery

Zip code


Address

Ogawahigashi-4-1-1, Kodaira, Tokyo, Japan

TEL

+81-42-341-2711

Homepage URL


Email

otsukit@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Lobour and Welfore

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



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

岡山大学病院(岡山県)、国立精神・神経医療研究センター病院(東京都)、国立病院機構静岡てんかん・神経医療センター(静岡県)、国立病院機構長崎医療センター(長崎県)、国立病院機構西新潟中央病院(新潟県)、自治医科大学付属病院(栃木県)、聖マリアンナ医科大学病院(神奈川県)、東京女子医科大学病院(東京都)、福岡大学病院(福岡県)、Samsung Medical Center (韓国ソウル市)、Yonsei 大学病院(韓国ソウル市)、Taipei Veterans General Hospital (台湾台北市)、Sanbo Brain Institute (中国北京市)


Other administrative information

Date of disclosure of the study information

2010 Year 08 Month 28 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

Enrolling by invitation

Date of protocol fixation

2010 Year 04 Month 27 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2013 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Items for investigation: age, gender, etiology, epileptic syndrome, EEG findings, MRI findings, age of onset, seizure type and frequency, treatment (medical, surgical) and response, developmental status, complications. follow-up 1 year, 3 years: seizure outcome, seizure type and frequency, development outcome, complications


Management information

Registered date

2010 Year 08 Month 28 Day

Last modified on

2010 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004954


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name