UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052869 |
|---|---|
| Receipt number | R000060332 |
| Scientific Title | Treatment persistence and adherence in patients with Parkinson's disease in Japan: a retrospective observational study using health insurance claim databases |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2025/05/28 17:41:19 |
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Basic information
Public title
Treatment persistence and adherence in patients with Parkinson's disease in Japan: a retrospective observational study using health insurance claim databases
Acronym
Treatment persistence and adherence in patients with Parkinson's disease in Japan: a retrospective observational study using health insurance claim databases
Scientific Title
Treatment persistence and adherence in patients with Parkinson's disease in Japan: a retrospective observational study using health insurance claim databases
Scientific Title:Acronym
Treatment persistence and adherence in patients with Parkinson's disease in Japan: a retrospective observational study using health insurance claim databases
Region
| Japan |
Condition
Condition
Parkison's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To descriptively analyze the adherence and persistence of newly initiated Parkinson's disease medication in patients with Parkinson's disease receiving oral levodopa treatment
Basic objectives2
Others
Basic objectives -Others
Pharmacoepidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Treatment adherence, and
2) Treatment persistence
during 1-year follow-up period
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Parkinson's disease receiving oral levodopa treatment who began taking an additional Parkinson's disease medication
Key exclusion criteria
Patients with a diagnosis of a disease that requires differentiation from Parkinson's disease
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ishida |
Organization
Eisai Co., Ltd.
Division name
Medical HQs
Zip code
112-8088
Address
Koishikawa 4-6-10, Bunkyo-ku, Tokyo
TEL
070-3762-8613
t8-ishida@hhc.eisai.co.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Ando |
Organization
Eisai Co., Ltd.
Division name
Medical HQs
Zip code
112-8088
Address
Koishikawa 4-6-10, Bunkyo-ku, Tokyo
TEL
080-6813-9330
Homepage URL
r2-ando@hhc.eisai.co.jp
Sponsor or person
Institute
Eisai Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.ac.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 | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1560431/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1560431/full
Number of participants that the trial has enrolled
7605
Results
7,605 patients were included in this analysis, with a mean age of 77.2 years, and 43.6% were male. The 1-year treatment persistence rate was 44.8%, and median persistent treatment duration over 1 year was 270.0 days. Persistence rates ranged from 28.6 to 59.5% across the drug cohorts, and were highest for zonisamide (59.5%) followed by safinamide (55.8%).
Results date posted
| 2025 | Year | 05 | Month | 28 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 05 | Month | 27 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 13 | Day |
Other
Other related information
A cohort study using health insurance claim databases
Management information
Registered date
| 2023 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060332
