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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015074
Receipt No. R000017537
Scientific Title Rare intractable epilepsy syndrome registry
Date of disclosure of the study information 2014/11/01
Last modified on 2019/03/11

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Basic information
Public title Rare intractable epilepsy syndrome registry
Acronym RES-R
Scientific Title Rare intractable epilepsy syndrome registry
Scientific Title:Acronym RES-R
Region
Japan

Condition
Condition Rare epilepsy syndrome
Classification by specialty
Neurology Pediatrics Psychiatry
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We collect the cases with rare intractable epilepsy (including various diseases with intractable epilepsy such as metabolic disorders or chromosomal anomalies) nationwide to obtain the approximate number of cases in Japan and estimate the mortality rate. We further perform a cross-sectional survey to reveal the actual conditions of patients and the relation between epilepsy duration and pathological status.
Basic objectives2 Others
Basic objectives -Others We follow up the patients for several years to disclose the evolution of the disorder and its effects on social condition.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death, intellectual development, neuro-psychiatric status, comorbid condition, seizure type and seizure frequency, EEG and imaging findings, treatment, psychosocial condition.
Evolutional changes of developmental status, seizure type and frequency, laboratory findings, social status as well as overall condition during the several years after onset.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Early myoclonic encephalopathy
Ohtahara syndrome
Epilepsy of infancy with migrating focal seizures
West syndrome
Dravet syndrome
Myoclonic status in nonprogressive encephalopathy
Epilepsy with myoclonic atonic seizures
Epilepsy with myoclonic absences
Lennox-Gastaut syndrome
Epileptic encephalopathy with continuous spike-and-wave during sleep (Electrical Status Epilepticus during Slow Sleep)
Landau-Kleffner syndrome
Progressive myoclonus epilepsies
Mesial temporal lobe epilepsy with hippocampal sclerosis
Rasmussen syndrome
Gelastic seizures with hypothalamic hamartoma
Hemiconvulsion-hemiplegia-epilepsy syndrome
Aicardi syndrome
Angelman syndrome
Rett syndrome
PCDH19-related epilepsy in females
Ring 20 chromosome syndrome
Focal epilepsy NOS
Generalized epilepsy NOS
Undetermined epilepsy NOS
Key exclusion criteria When attending physician considers the patient inappropriate to include in the study.
When there is no causative disorder in case of focal epilepsy NOS, generalized epilepsy NOS or Undetermined epilepsy NOS.
When the onset date of epilepsy is uncertain.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yushi
Middle name
Last name Inoue
Organization NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Division name Clinical Research Division
Zip code 420-8688
Address Urushiyama 886 Aoi-ku, Shizuoka 420-8688, Japan
TEL 054-245-5446
Email shizuoka@hosp.go.jp

Public contact
Name of contact person
1st name Yushi
Middle name
Last name Inoue
Organization NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Division name Clinical Research Division
Zip code 420-8688
Address Urushiyama 886 Aoi-ku, Shizuoka 420-8688, Japan
TEL 054-245-5446
Homepage URL http://www.res-r.com
Email contact@res-r.com

Sponsor
Institute NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Institute
Department

Funding Source
Organization Research Grant, Ministry of Health, Labor and Welfare, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Address Urushiyama 886 Aoi-ku, Shizuoka 420-8688, Japan
Tel 054-245-5446
Email contact@res-r.com

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 東京女子医大病院(東京都)
福岡大学病院(福岡県)
新潟大学脳研究所(新潟県)
北海道大学病院(北海道)
東北大病院(宮城県)
聖マリアンナ医科大学病院(神奈川県)
西新潟中央病院(新潟県)
国立精神・神経医療研究センター(東京都)
大阪大学病院(大阪府)
岡山大学病院(岡山県)
長崎医療センター(長崎県)
京都大学病院(京都府)
自治医科大学病院(栃木県)
愛知医大病院(愛知県)
埼玉県立小児医療センター(埼玉県)
順天堂大学病院(東京都)
久留米大学病院(福岡県)
大阪府立母子保健総合医療センター(大阪府)
NTT東日本関東病院(東京都)
東京都立神経病院(東京都)
県立延岡病院(宮崎県)
東京医科歯科大学医学部附属病院(東京都)
昭和大学病院(東京都)
医療法人社団浅ノ川 浅ノ川総合病院
岩手医科大学附属病院(岩手県)
聖マリア病院(福岡県)

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 01 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
2014 Year 09 Month 15 Day
Date of IRB
2014 Year 01 Month 30 Day
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study consists of case registry, cross-sectional survey and longitudinal survey. Registered will be the information around epilepsy onset, diagnosis and causative disorder. Cross-sectional survey analyses the epilepsy-related data collected for a period of 13 months from the start of registry, retrospectively. Longitudinal survey follows up the new-onset cases registered during 13 months from the start of registry for several years prospectively.

Management information
Registered date
2014 Year 09 Month 06 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017537

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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