UMIN-CTR Clinical Trial

Basic information
Public title	Study about perception of Parkinson's disease progression among patients with Parkinson's disease and physicians in Japan
Acronym	Study about perception of Parkinson's disease progression among patients with Parkinson's disease and physicians
Scientific Title	Study about perception of Parkinson's disease progression among patients with Parkinson's disease and physicians in Japan
Scientific Title:Acronym	Study about perception of Parkinson's disease progression among patients with Parkinson's disease and physicians
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the perception of the presence of symptoms among patients with Parkinson's disease (PD) and their treating physicians.
Basic objectives2	Others
Basic objectives -Others	See above
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The proportion of individuals reporting current Wearing-off(WO) as recognized by Wearing-off Questionnaire performed by patients and physician's judgment.
Key secondary outcomes	The main secondary endpoints are as follows: -The proportion of individuals reporting morning akinesia among patients and physicians -The patient's QOL assessed among patients and physicians

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients, who fulfill the following criteria, can be included: -Adult patients with confirmed diagnosis of PD who receive any PD treatments for more than 1 year, continuously. -Willingness and ability to sign informed consent. Physicians, who fulfill the following criteria, can be included: -Who have more than five patients with PD matching the criteria above -Willingness and ability to provide informed consent
Key exclusion criteria	-Patients who are not able to complete the questionnaires by themselves and have no support for questionnaire completion by their caregivers. -Patients and physicians who cannot submit the questionnaire in 14 days after the appointment.
Target sample size	210

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Mikami
Organization	AbbVie GK
Division name	Medical Affairs
Zip code	108-0023
Address	3-1-21 Shibaura, Minato-ku, Tokyo 108-6302, Japan
TEL	03-4577-1111
Email	osamu.mikami@abbvie.com

Public contact
Name of contact person	1st name Jun Middle name Last name Watanabe
Organization	AbbVie GK
Division name	Medical Affairs
Zip code	108-0023
Address	3-1-21 Shibaura, Minato-ku, Tokyo 108-6302, Japan
TEL	03-4577-1111
Homepage URL
Email	jun.watanabe@abbvie.com

Sponsor
Institute	AbbVie GK
Institute
Department

Funding Source
Organization	AbbVie GK
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Non-Profit Organization MINS IRB
Address	Mita 5-20-9-401, Minato-ku, Tokyo, Japan
Tel	03-6416-1868
Email	npo-mins@j-irb.com

Secondary IDs
Secondary IDs	YES
Study ID_1	P18-900
Org. issuing International ID_1	AbbVie GK
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	株式会社アンテリオ/ ANTERIO Inc.

Other administrative information
Date of disclosure of the study information	2018 Year 05 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	No longer recruiting
Date of protocol fixation	2018 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date	2018 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This observational study will be performed in a cross-sectional, non-interventional, single-country format. The questionnaires will be provided to physicians and the physician will give the questionnaire to patient in the appointment. Completed questionnaires will be collected anonymously by return mail.

Management information
Registered date	2018 Year 05 Month 10 Day
Last modified on	2020 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037063