UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019940 |
|---|---|
| Receipt number | R000023027 |
| Scientific Title | Seizure Outcomes and Predictors of Recurrent Post-stroke Seizure:A prospective observational cohort study |
| Date of disclosure of the study information | 2015/11/29 |
| Last modified on | 2020/01/13 17:33:16 |
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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
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
tanakat@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023027
