UMIN-CTR Clinical Trial

Basic information
Public title	Seizure Outcomes and Predictors of Recurrent Post-stroke Seizure:A prospective observational cohort study
Acronym	PROgnosis of Post Stroke Epilepsy (PROPOSE) study
Scientific Title	Seizure Outcomes and Predictors of Recurrent Post-stroke Seizure:A prospective observational cohort study
Scientific Title:Acronym	PROgnosis of Post Stroke Epilepsy (PROPOSE) study
Region	Japan

Condition
Condition	Post stroke seizure
Classification by specialty	Neurology Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify reliable predictors of recurrent seizure in patients with late seizures and to evaluate the outcome of different AED regimens for secondary prevention.
Basic objectives2	Others
Basic objectives -Others	We compared baseline clinical characteristics and post-stroke treatment regimens between recurrent and non-recurrent PSS patients to identify factors predictive of recurrence.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	recurrence of post stroke seizure
Key secondary outcomes	compliance of antiepileptic drugs

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 diagnosed with seizure and selected patients with a history of preceding stroke. seizures occurring at least one weeks after stroke were defined as late seizures.
Key exclusion criteria	1. acute symptomatic seizure 2. non poststroke seizure 3. patient who reject to be recruited
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Tomotaka Middle name Last name Tanaka
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Stroke and Cerebrovascular Diseases
Zip code	564-8565
Address	6-1 Kishibe-Shimmachi, Suita, Osaka, Japan
TEL	06-6170-1070
Email	tanakat@hsp.ncvc.go.jp

Public contact
Name of contact person	1st name Tomotaka Middle name Last name Tanaka
Organization	Department of Stroke and Cerebrovascular Diseases
Division name	Department of Stroke and Cerebrovascular Diseases
Zip code	564-8565
Address	6-1 Kishibe-Shimmachi, Suita, Osaka, Japan
TEL	06-6170-1070
Homepage URL
Email	tanakat@hsp.ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	National Cerebral and Cardiovascular Center
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	National Cerebral and Cardiovascular Center
Address	6-1 Kishibe-Shimmachi, Suita, Osaka, Japan
Tel	06-6170-1070
Email	tanakat@hsp.ncvc.go.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	・京都大学,運動異常生理学講座 ・神戸市立医療センター中央市民病院,神経内科 ・東京都健康長寿医療センター,神経内科 ・中村記念病院,神経内科 ・聖マリア病院　脳血管内科 ・トヨタ記念病院　神経内科 ・熊本済生会病院　神経内科 ・独立行政法人国立病院機構　岡山医療センター　神経内科

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 29 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	No longer recruiting
Date of protocol fixation	2014 Year 11 Month 06 Day
Date of IRB	2018 Year 03 Month 30 Day
Anticipated trial start date	2014 Year 11 Month 10 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design:prospective observational cohort study Study population: Patients with post stroke seizures admitted to our department between November 2014 and September 2018. Outcomes: Information regarding recurrent seizure was collected through inspection of inpatient and outpatient records or telephone inquiry with the patients themselves or relatives: the seizure recurrence, efficacy and modifications of AEDs and neurological status are recorded. The following demographic and clinical characteristics are collected from medical records: age, sex, previous stroke type, previous late seizures, traumatic brain injury, neurosurgical intervention, dementia, family history of epilepsy, smoking, drinking alcohol, and stroke risk factors. We also check blood test, MR image, SPECT, EEG.

Management information
Registered date	2015 Year 11 Month 26 Day
Last modified on	2020 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023027