UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030238 |
|---|---|
| Receipt number | R000033457 |
| Scientific Title | A Study of Dexstromethorphan Therapy for Febrile Status Epilepticus Patients against Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion and Prevention for Residual Disability |
| Date of disclosure of the study information | 2018/02/28 |
| Last modified on | 2021/06/07 12:24:58 |
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Basic information
Public title
A Study of Dexstromethorphan Therapy for Febrile Status Epilepticus Patients against Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion and Prevention for Residual Disability
Acronym
A Study of Dexstromethorphan Therapy for Febrile Status Epilepticus Patients against Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion and Prevention for Residual Disability
Scientific Title
A Study of Dexstromethorphan Therapy for Febrile Status Epilepticus Patients against Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion and Prevention for Residual Disability
Scientific Title:Acronym
A Study of Dexstromethorphan Therapy for Febrile Status Epilepticus Patients against Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion and Prevention for Residual Disability
Region
| Japan |
Condition
Condition
febrile status epilepticus
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will seek to examine the usefulness of dextromethruphan for acute encephalopathy with biphasic seizures(AESD) and late reduced diffuion and following residural disability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome are occuring second seizures and consiousness disorder in 3-7 days after first seizure.
Key secondary outcomes
Secondary outcomes are age(between six months and one year versus between one and three years), sex, duration of seizure(less than 45 minutes versus more than 45 minutes), past history(whether patients experience feblire seizure or not), and value of AST and blood suger at admission.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patient filling inclution criteria are started on Dextromethrophan 2mg/kg/day within 6hours after status epilepticus for 5 days.
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
| 6 | months-old | <= |
Age-upper limit
| 36 | months-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects are patients who meet following three inclusion criteria
1) Patients who are 6 months of age more but less than 3 years of age
2) Patients with status epilepticus(patients have convulsion more than 15 minutes)
3)Patients whose convulsion could not been stoped quickly using the first choise therapy(diazepam or midazoram) and the second choise therapy(phenytoin)(However, in regard to using continuous idazoram infusion, the case using as a second choise and failing to stop convulsion meets criteria)
Key exclusion criteria
The sujects are patients who meet following five exclusion criteria
1) Patients who are clearly suspitious of intracranial infection, cranial tumor and intracranial vascular lesion
2) patients who are clearly cranial hemorrhage for head MRI and CT in 1 or 2 days after occuring status epilepticus
3) Patients Who are acute necrotizing encephalopathy
4) Patients who already take antiepileptic drugs against epilepsy
5) Patients who already take dextromethrophan against upper respiratory infection
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Morio |
Organization
Tokyo Medical and Dental University
Division name
Department of Pediatrics
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyou ward, Tokyo
TEL
03-3813-6111
tmorio.ped@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Moriyama |
Organization
Tokyo Medical and Dental University
Division name
Department of Pediatrics
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyou ward, Tokyo
TEL
03-3813-6111
Homepage URL
kmoriyama.ped@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Department of Pediatrics
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Hospital of Medicine, Clinical Research Center
Address
1-5-45, Yushima, Bunkyou ward, Tokyo
Tel
03-5803-5612
tiken.crc@tmd.ac.jp
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
東京医科歯科大学医学部付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | 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
| Delay expected |
Results Delay Reason
Because it needs more time to consider statistical examinations as a advance preparation and their protocols
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 03 | Day |
Last modified on
| 2021 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033457
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