UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease
Title of the study (Brief title)	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	Masahisa Katsuno
Organization	Nagoya university graduate school of medicine
Division name	neurology
Address	65 Tsurumai-cho,Showa-ku,Nagoya
TEL	052-744-2391
Email	ka2no@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tomohiko Nakamura
Organization	Nagoya university graduate school of medicine
Division name	inspection unit
Address	65 Tsurumai-cho,Showa-ku,Nagoya
TEL	052-744-2391
Homepage URL
Email	tomohiko@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029643