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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030238
Receipt No. 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 2017/12/03

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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
Middle name
Last name Tomohiro Morio
Organization Tokyo Medical and Dental University
Division name Department of Pediatrics
Zip code
Address 1-5-45, Yushima, Bunkyou ward, Tokyo
TEL 03-3813-6111
Email tmorio.ped@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Moriyama
Organization Tokyo Medical and Dental University
Division name Department of Pediatrics
Zip code
Address 1-5-45, Yushima, Bunkyou ward, Tokyo
TEL 03-3813-6111
Homepage URL
Email kmoriyama.ped@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Department of Pediatrics
Institute
Department

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
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 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
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 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
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
2017 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033457

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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