UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046823 |
|---|---|
| Receipt number | R000053425 |
| Scientific Title | Prescribing patterns for elderly Parkinson's disease in Japan using claims data |
| Date of disclosure of the study information | 2022/02/03 |
| Last modified on | 2024/07/05 09:59:04 |
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Basic information
Public title
Prescribing patterns for elderly Parkinson's disease in Japan using claims data
Acronym
Prescribing patterns for elderly Parkinson's disease in Japan using claims data
Scientific Title
Prescribing patterns for elderly Parkinson's disease in Japan using claims data
Scientific Title:Acronym
Prescribing patterns for elderly Parkinson's disease in Japan
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the actual status of prescribing among the elderly patients with Parkinson's disease
Basic objectives2
Others
Basic objectives -Others
Longitudinal analysis of the treatment of elderly patients with Parkinson's disease to clarify the characteristics, issues, and trends to be considered in elderly patients with Parkinson's disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prescribing patterns of anti-Parkinson's diseases drugs
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients who have been identified Parkinson's disease (G20) for more than 6 months and have been prescribed at least one anti-PD drug for more than 6 months, at least twice.
Key exclusion criteria
Patients under 30 years of age and patients with Parkinson's disease syndrome
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Fujikawa |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo
TEL
03-3278-2111
keita.fujikawa@takeda.com
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Arai |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo
TEL
03-3278-2111
Homepage URL
arai.masaki@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research institute of healthcare data science
Address
Sumitomo Shiba-Daimon Building 12F, 2-5-5 Shiba-Daimon, Minato-ku, Tokyo
Tel
03-5733-5010
rihds@jmdc.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
| 2022 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fneur.2023.1162016/full
Number of participants that the trial has enrolled
39731
Results
Of the 18 million people, 39,731 met eligibility criteria, with a PD prevalence of 1.21 per 100 people aged 75 yo and over. Levodopa was the most prescribed anti-PD drug (overall: 85.4%; aged 75 yo and over: 88.3%). Older patients were mainly switched from levodopa monotherapy to adjunctive prescriptions, with monoamine oxidase type B inhibitors, non-ergot dopamine agonists and zonisamide used as adjunctive therapies. Adjunct levodopa tended to be prescribed at levodopa doses of 300 mg, regardless of age.
Results date posted
| 2023 | Year | 07 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with PD (30 years or older, ICD-10: G20 excluding Parkinson's syndrome)
Participant flow
DB analysis
Adverse events
N.A.
Outcome measures
See key results section
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2022 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053425
| Research Plan | |
|---|---|
| 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 |
