UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053427 |
|---|---|
| Receipt number | R000060976 |
| Scientific Title | Clinical Study on the Disease-Modifying Effects of Rasagiline on Parkinson's Disease Using Machine Learning |
| Date of disclosure of the study information | 2024/01/24 |
| Last modified on | 2025/05/01 14:18:09 |
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Basic information
Public title
Clinical Study on the Disease-Modifying Effects of Rasagiline on Parkinson's Disease Using Machine Learning
Acronym
Clinical Study on the Disease-Modifying Effects of Rasagiline on Parkinson's Disease Using Machine Learning
Scientific Title
Clinical Study on the Disease-Modifying Effects of Rasagiline on Parkinson's Disease Using Machine Learning
Scientific Title:Acronym
Clinical Study on the Disease-Modifying Effects of Rasagiline on Parkinson's Disease Using Machine Learning
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To analyze the disease-modifying effect of rasagiline in patients with Parkinson's disease and to evaluate its efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical symptoms at baseline, 24, 48, 72, and 96 weeks (UPDRS).
Key secondary outcomes
Blood test, brain MRI scan
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with Parkinson's disease to be additionally treated with rasagiline 1 mg/day.
Interventions/Control_2
Patients with Parkinson's disease who do not take rasagiline.
Interventions/Control_3
Patients with Parkinson's disease who were treated with rasagiline alone 1 mg/day
Interventions/Control_4
Healthy subjects
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with sporadic Parkinson's disease attending the Department of Neurology at Juntendo University Hospital. Patients who have received an explanation of this study, understand its contents, and give their consent.
Key exclusion criteria
(1) Patients with severely impaired renal function
(2) Patients who are pregnant or may be pregnant
(3) Patients who are breast-feeding
(4) Patients suffering from collagen disease, vasculitis disease, malignant tumor, or severe diabetes mellitus
(5) Other patients who are deemed inappropriate as subjects by the principal investigator.
Target sample size
325
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Saiki |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
ssaiki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Saiki |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
ssaiki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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 | 01 | Month | 24 | 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
151
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060976
