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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004120
Receipt No. 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

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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
Institute National Center of Neurology and Psychiatry
Institute
Department

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
URL(English) https://upload.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


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