UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026128 |
|---|---|
| Receipt number | R000029643 |
| Scientific Title | Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/08/29 13:29:50 |
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Basic information
Public title
Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease
Acronym
Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease
Scientific Title
Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease
Scientific Title:Acronym
Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reserch the association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pupil light reflex evaluation with pupillometry
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administe pilocarpine and dipivefrine
Interventions/Control_2
administe pilocarpine and dipivefrine
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parkinsonism
Normal within brain CT or MRI
Not taking any drugs causing parkinsonism
Antiparkinson drug is efficacious
Key exclusion criteria
diabate
peripheral neuropathy
eye disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahisa Katsuno |
Organization
Nagoya university graduate school of medicine
Division name
neurology
Zip code
Address
65 Tsurumai-cho,Showa-ku,Nagoya
TEL
052-744-2391
ka2no@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Nakamura |
Organization
Nagoya university graduate school of medicine
Division name
inspection unit
Zip code
Address
65 Tsurumai-cho,Showa-ku,Nagoya
TEL
052-744-2391
Homepage URL
tomohiko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education culture,sports,science and technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 14 | Day |
Last modified on
| 2018 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029643
