UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000039717