UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009659
Receipt number R000011335
Scientific Title investigation of post stroke epilepsy study
Date of disclosure of the study information 2012/12/28
Last modified on 2018/09/03 12:13:46

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Basic information

Public title

investigation of post stroke epilepsy study

Acronym

INPOSE study

Scientific Title

investigation of post stroke epilepsy study

Scientific Title:Acronym

INPOSE study

Region

Japan


Condition

Condition

cerebral stroke, epilespy

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

study for the rate of epilepsy and its risk factor of the patient after cerebral stroke

Basic objectives2

Others

Basic objectives -Others

observational study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

onset of epilepsy, MRI findings, lifestyle

Key secondary outcomes



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

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with cerebral stroke

Key exclusion criteria

transient ischemic attach, death within 72hrs after onset, past history of epilepsy

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Nakase

Organization

Nara Medical University

Division name

Department of Neurosurgery

Zip code


Address

840 Shijo-cho, Kashihara, Nara

TEL

0744-22-3051

Email

inpose@naramed-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shuichi Yamada

Organization

Nara Medical University

Division name

Department of Neurosurgery

Zip code


Address

840 Shijo-cho, Kashihara city, Nara, JAPAN

TEL

0744-22-3051

Homepage URL


Email

inpose@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University, Department of Neurosurgery

Institute

Department

Personal name



Funding Source

Organization

Nara Medical University, Department of Neurosurgery

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



Other administrative information

Date of disclosure of the study information

2012 Year 12 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

Completed

Date of protocol fixation

2012 Year 11 Month 22 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 22 Day

Last follow-up date

2018 Year 07 Month 31 Day

Date of closure to data entry

2018 Year 07 Month 31 Day

Date trial data considered complete

2018 Year 09 Month 30 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information

examination was closed
data are analyzing


Management information

Registered date

2012 Year 12 Month 28 Day

Last modified on

2018 Year 09 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011335


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name