UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015074 |
|---|---|
| Receipt number | R000017537 |
| Scientific Title | Rare intractable epilepsy syndrome registry |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2025/03/15 09:14:53 |
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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
5000
Research contact person
Name of lead principal investigator
| 1st name | Katsumi |
| Middle name | |
| Last name | Imai |
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
contact@res-r.com
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
contact@res-r.com
Sponsor or person
Institute
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Institute
Department
Personal name
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
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
Partially published
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
| 2026 | 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
| 2025 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017537
