UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034826 |
|---|---|
| Receipt number | 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 09:09:55 |
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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
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
van.tomoaki@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039717
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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