UMIN-CTR Clinical Trial

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
Email	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
Email	eisei@dokkyomed.ac.jp

Sponsor
Institute	Japan Resuscitation Council (JRC)
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045525

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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