UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032542 |
|---|---|
| Receipt number | 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 | 2020/05/26 15:33:32 |
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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 | 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
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
jun.watanabe@abbvie.com
Sponsor or person
Institute
AbbVie GK
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
