UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039934 |
|---|---|
| Receipt number | R000045525 |
| Scientific Title | Phenytoin versus other antiepileptic drugs for status epilepticus in adults: a systematic review and meta -analysis. |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/03/25 15:31:51 |
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Basic information
Public title
Phenytoin versus other antiepileptic drugs for status epilepticus in adults: a systematic review and meta -analysis.
Acronym
Phenytoin versus other antiepileptic drugs for status epilepticus in adults: a systematic review and meta -analysis.
Scientific Title
Phenytoin versus other antiepileptic drugs for status epilepticus in adults: a systematic review and meta -analysis.
Scientific Title:Acronym
Phenytoin versus other antiepileptic drugs for status epilepticus in adults: a systematic review and meta -analysis.
Region
| Japan |
Condition
Condition
Status epilepticus
Classification by specialty
| Medicine in general | Neurology | Emergency medicine |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
From clinical study conducted in adult status epilepticus patients, the systematic analysis method of clinical research papers was used to systematically analyze the efficacy of phenytoin intervention for status epilepticus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Mortality at hospital discharge
2. Neurological outcome
3. Seizure with no recurrence
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
status epilepticus in adults
Interventions
phenytoin
Control
other epileptic drugs
Outcome
1. mortality at hospital discharge
2. neurological outcome
3. seizure with no recurrence
Key exclusion criteria
Adolescents (under 15 years of age)
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Eisei |
| Middle name | |
| Last name | Hoshiyama |
Organization
Dokkyo Medical University
Division name
Department of Neurology, Emergency and Critical Care Center
Zip code
3200293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan
TEL
0282-86-1111
eisei@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Eisei |
| Middle name | |
| Last name | Hoshiyama |
Organization
Dokkyo Medical University
Division name
Department of Neurology, Emergency and Critical Care Center
Zip code
3200293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan
TEL
0282-86-1111
Homepage URL
eisei@dokkyomed.ac.jp
Sponsor or person
Institute
Japan Resuscitation Council (JRC)
Institute
Department
Personal name
Funding Source
Organization
Japan Resuscitation Council (JRC)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan
Tel
0282-86-1111
eisei@dokkyomed.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | 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
0
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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Potentially eligible trials will be identified by searching the MEDLINE (via PubMed), the Cochrane Central Register of Controlled Trials (CENTRAL), Japana Centra revuo Medicina Web in August 15, 2019 to identify RCTs which compare the mortality between phenytoin versus other antiepileptic drugs for status epilepticus in adult status epilepticus patients. There will be no date restrictions applied in any of the searches and all searched publications with English abstracts will be included.
Management information
Registered date
| 2020 | Year | 03 | Month | 25 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045525
