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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032542
Receipt No. R000037063
Scientific Title Study about perception of Parkinson's disease progression among patients with Parkinson's disease and physicians in Japan
Date of disclosure of the study information 2018/05/13
Last modified on 2018/11/16

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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
Middle name
Last name Osamu Mikami
Organization AbbVie GK
Division name Medical Affairs
Zip code
Address 3-5-27, Mita, Minato-ku, Tokyo 108-6302, Japan
TEL 03-4577-1111
Email osamu.mikami@abbvie.com

Public contact
Name of contact person
1st name
Middle name
Last name Ryoko Nakagawa
Organization AbbVie GK
Division name Medical Affairs
Zip code
Address 3-5-27, Mita, Minato-ku, Tokyo 108-6302, Japan
TEL 03-4577-1111
Homepage URL
Email ryoko.nakagawa@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
Address
Tel
Email

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
2018 Year 11 Month 16 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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