UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018259 |
|---|---|
| Receipt number | R000021123 |
| Scientific Title | multicentric cohort study for acute encephalopathy with biphasic seizures and late reduced diffusion |
| Date of disclosure of the study information | 2015/07/15 |
| Last modified on | 2015/07/09 19:58:13 |
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Basic information
Public title
multicentric cohort study for acute encephalopathy with biphasic seizures and late reduced diffusion
Acronym
registry-AESD
Scientific Title
multicentric cohort study for acute encephalopathy with biphasic seizures and late reduced diffusion
Scientific Title:Acronym
registry-AESD
Region
| Japan |
Condition
Condition
acute encephalopathy with biphasic seizures and late reduced diffusion (AESD)
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy of current treatments for acute encephalopathy with biphasic seizures and late reduced diffusion (AESD) by multicentric, registry-formed cohort study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes of the rate of patients with score 1 and 2 by Pediatric Cerebral Performance Category Scale (PCPC scale)
Key secondary outcomes
surveillance of current therapeutic regimen for AESD
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
patients who presented first and second phase (biphasic) seizures:
1) seizures during febrile (37.5 degrees C or higher) illness (first phase seizures)
2) secondary seizures with 24-hour or longer interval after first phase seizures (second phase seizures)
Key exclusion criteria
1) biphasic seizures induced by the disorders other than AESD, e.g., meningitis/encephalitis caused by pathogenic organism or immunological mechanism, other types of acute encephalopathies, epileptic seizures, disorders by unknown etiology but obviously different from AESD
2) judged as inappropriate for this study by investigators
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohide Goto, Sahoko Miyama |
Organization
Kanagawa Children's Medical Center, Tokyo Metropolitan Children's Medical Center
Division name
Division of Neurology
Zip code
Address
2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa232-0066, Japan
TEL
045-711-2351
tgoto@kcmc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuri Sakaguchi |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Neurology
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo183-8561, Japan
TEL
042-300-5111
Homepage URL
sn_AESD@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Hospital Group
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 07 | Month | 15 | 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 | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | 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
to evaluate the efficacy of current treatments for acute encephalopathy with biphasic seizures and late reduced diffusion (AESD) by multicentric, registry-formed cohort study
Management information
Registered date
| 2015 | Year | 07 | Month | 09 | Day |
Last modified on
| 2015 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021123
