UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054993 |
|---|---|
| Receipt number | R000061640 |
| Scientific Title | A retrospective observational study of rasagiline combination therapy in early-stage Parkinson's disease patients treated with levodopa |
| Date of disclosure of the study information | 2024/07/18 |
| Last modified on | 2025/03/07 11:17:00 |
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Basic information
Public title
A retrospective observational study of rasagiline combination therapy in early-stage Parkinson's disease patients treated with levodopa
Acronym
A retrospective observational study of rasagiline combination therapy in early-stage Parkinson's disease patients treated with levodopa
Scientific Title
A retrospective observational study of rasagiline combination therapy in early-stage Parkinson's disease patients treated with levodopa
Scientific Title:Acronym
A retrospective observational study of rasagiline combination therapy in early-stage Parkinson's disease patients treated with levodopa
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a Patient Registry for Backward-Looking Observations in Patients with Early Parkinson's Disease
Basic objectives2
Others
Basic objectives -Others
A backward-looking observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in MDS-UPDRS PART3 score between baseline and follow-up periods
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who fall into any of the following categories shall be included.
(1) Patients who received * less than or equal to 300 mg/day of levodopa for more than a certain period of time during the follow-up period and subsequently received additional rasagiline.
(2) Patients who received * less than or equal to 300 mg/day of levodopa for more than a certain period of time during the follow-up period and subsequently received an increase in the dose of levodopa.
*The number of days to ensure the necessary number of patients should be considered after conducting a feasibility study.
The index date will be the date of the first dose of lasagiline in (1) and the date of dose escalation from the maximum dose of levodopa of 300 mg/day or less in (2).
The patients in (1) will be designated as subgroup 1, and those in (2) as subgroup 2.
Key exclusion criteria
Exclude patients who meet the following criteria
Patients with a history of DBS prior to the Index date
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Miwa |
| Middle name | |
| Last name | Izutsu |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3278-2111
miwa.izutsu@takeda.com
Public contact
Name of contact person
| 1st name | Kiyoto |
| Middle name | |
| Last name | Naito |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3278-2111
Homepage URL
kiyoto.naito@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
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital Clinical Research Ethics Review Committee
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576 Japan
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
| 2024 | Year | 07 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study in Parkinson's disease patients using a patient registry
Management information
Registered date
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061640
