UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051513 |
|---|---|
| Receipt number | R000058767 |
| Scientific Title | Important treatment attributes considered by Japanese patients with advanced Parkinson's disease (aPD) |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2024/03/18 10:23:59 |
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Basic information
Public title
Important treatment attributes considered by Japanese patients with advanced Parkinson's disease (aPD)
Acronym
Important treatment attributes considered by Japanese patients with advanced Parkinson's disease (aPD)
Scientific Title
Important treatment attributes considered by Japanese patients with advanced Parkinson's disease (aPD)
Scientific Title:Acronym
Important treatment attributes considered by Japanese patients with advanced Parkinson's disease (aPD)
Region
| Japan |
Condition
Condition
Advanced Parkinson's disease (aPD)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to identify key attributes (features of treatment) that Japanese patients with PD and poor motor symptom control with orals/applied patch therapy consider when choosing treatments for advanced Parkinson's disease (aPD) using the Discrete Choice Experiment (DCE) methodology.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The preference weight and the relative importance (%) of the attributes will be identified by the phase 1 interview conducted in this study in Japanese aPD patients.
Key secondary outcomes
The preference weight and the relative importance (%) of each attribute in each patient subgroup.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of Parkinson's Disease (confirmed by a physician)
2) Adults (30 years of age or older)
3) Receiving PD treatment (oral medications and/or applied therapy) in Japan
4) Patients who meet any of the 5-2-1 criteria (defined by physicians)
a. Taking oral levodopa five or more times per day
b. Off time for more than 2 hours per day
c. Troublesome dyskinesia for more than 1 hour per day
5) Able to respond to this survey by themselves (assistance for entering their answers to the web-based questionnaire by their caregivers is allowed)
6) Given consent to the study
Key exclusion criteria
1) Patients with experience in any device-aided therapy (DATs; CSCI, LCIG, or DBS) or FUS
2) Patients with impaired cognitive function (e.g., MMSE under 23, taking medicine for Alzheimer's disease or cognitive impairment (specifically: donepezil HCl, rivastigmine transdermal system, galantamine, galantamine HBr, memantine HCI)), or psychosis (either past history or current)
3) Patients with a diagnosis of atypical or secondary Parkinsonism
4) Patients with visual impairment significant enough that they cannot comply with the study procedures
5) Did not provide consent to participate (and record the interview)
6) Is not willing nor able to comply with procedures required in this protocol
7) Patients who are pregnant
8) Not fluent in Japanese
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kimino |
| Middle name | |
| Last name | Fujimura |
Organization
AbbVie GK.
Division name
Medical/ Medical Affairs/ Specialty/ Neurology
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo
TEL
090-8485-8296
kimino.fujimura@abbvie.com
Public contact
Name of contact person
| 1st name | Kimino |
| Middle name | |
| Last name | Fujimura |
Organization
AbbVie GK.
Division name
Medical/ Medical Affairs/ Specialty/ Neurology
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo
TEL
090-8485-8296
Homepage URL
kimino.fujimura@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
Institutional Review Board of Takahashi Clinic
Address
5-1-31 Iwayakita-machi, Nada-ku, Kobe-shi, Hyogo
Tel
078-882-6432
kishimoto.satoshi@neues.co.jp
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
| 2023 | Year | 08 | 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
| 2023 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will collect information from patients with advanced Parkinson's disease through web-based interviews and questionnaires.
The information collected is the information shown in the endpoints.
Management information
Registered date
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058767
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
