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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034826
Receipt No. R000039717
Scientific Title To evaluate the influence of anti-epileptic drugs on car driving ability.
Date of disclosure of the study information 2018/11/13
Last modified on 2019/05/20

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Basic information
Public title To evaluate the influence of anti-epileptic drugs on car driving ability.
Acronym Car driving ability of those taking anti-epileptic drugs
Scientific Title To evaluate the influence of anti-epileptic drugs on car driving ability.
Scientific Title:Acronym Car driving ability of those taking anti-epileptic drugs
Region
Japan

Condition
Condition Epilepsy
Classification by specialty
Neurology Psychiatry Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to elucidate the influence of anti-epileptic drugs on car driving ability.
We compare the driving ability of people whose seizure has disappeared due to taking anti-epileptic drugs and those who are not taking anti-epileptic drugs.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence or absence of decline in car driving ability with talking anti-epileptic drugs.
Key secondary outcomes Car driving ability
- Simple reaction
- Selection reaction
- Handle operation
- Attention allocation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 AED dose group: The patient carries out virtual driving tasks.
Interventions/Control_2 Control group: The patient carries out virtual driving tasks.
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria AED dose group
- People whose seizure has disappeared due to taking anti-epileptic drugs

Control group
- People who are not taking anti-epileptic drugs
Key exclusion criteria People who have an abnormality in cognitive function
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kensuke
Middle name
Last name Kawai
Organization Jichi Medical University
Division name Department of Neurosurgery
Zip code 3290498
Address 3311-1, Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7373
Email kenkawai-tky@jichi.ac.jp

Public contact
Name of contact person
1st name Tomoaki
Middle name
Last name Ban
Organization Jichi Medical University
Division name Department of Neurosurgery
Zip code 329-0498
Address 3311-1, Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7373
Homepage URL
Email van.tomoaki@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
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 Jichi Medical University
Address 3311-1, Yakushiji, Shimotsuke, Tochigi
Tel 0285-58-7550
Email rinri@jichi.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
2018 Year 11 Month 13 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 Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 18 Day
Date of IRB
2018 Year 11 Month 07 Day
Anticipated trial start date
2018 Year 12 Month 03 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 09 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039717

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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