UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054115 |
|---|---|
| Receipt number | R000061797 |
| Scientific Title | Prospective Observational Study for Parkinson's Disease |
| Date of disclosure of the study information | 2024/04/11 |
| Last modified on | 2024/04/11 17:30:03 |
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Basic information
Public title
Prospective Observational Study for Parkinson's Disease
Acronym
Prospective Observational Study for Parkinson's Disease
Scientific Title
Prospective Observational Study for Parkinson's Disease
Scientific Title:Acronym
Prospective Observational Study for Parkinson's Disease
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Explore issues that arise during treatment with levodopa formulations in patients with Parkinson's disease.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate blood SAM levels at each observation point
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with Parkinson's disease
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Sugeno |
Organization
Tohoku University, School of Medicine
Division name
Department of Neurology
Zip code
980-8574
Address
1-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-7189
naoto.sugeno.d5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Sugeno |
Organization
Tohoku University, School of Medicine
Division name
Department of Neurology
Zip code
980-8574
Address
1-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-7189
Homepage URL
naoto.sugeno.d5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Tohoku University, School of Medicine
Address
1-1 Seiryomachi, Aobaku, Sendai
Tel
022-717-7189
naoto.sugeno.d5@tohoku.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 | 04 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061797
