UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059699 |
|---|---|
| Receipt number | R000067841 |
| Scientific Title | Observational Study on the Efficacy and Adverse Effects of Foslevodopa Foscarbidopa Continuous Subcutaneous Infusion (FOCS) |
| Date of disclosure of the study information | 2025/11/08 |
| Last modified on | 2025/11/08 14:47:05 |
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Basic information
Public title
Observational Study on the Efficacy and Adverse Effects of Foslevodopa Foscarbidopa Continuous Subcutaneous Infusion (FOCS)
Acronym
Observational Study on the Efficacy and Adverse Effects of Foslevodopa Foscarbidopa Continuous Subcutaneous Infusion (FOCS)
Scientific Title
Observational Study on the Efficacy and Adverse Effects of Foslevodopa Foscarbidopa Continuous Subcutaneous Infusion (FOCS)
Scientific Title:Acronym
Observational Study on the Efficacy and Adverse Effects of Foslevodopa Foscarbidopa Continuous Subcutaneous Infusion (FOCS)
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This retrospective chart review included patients who received Foslevodopa Foscarbidopa Continuous Subcutaneous Infusion (FOCS) at our hospital, with the objective of identifying and characterizing issues arising during the clinical management of FOCS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint:
The dropout rate following initiation of Foslevodopa Foscarbidopa Continuous Subcutaneous Infusion (FOCS).
Secondary endpoints:
Time to onset and types of FOCS related complications, as well as information regarding the management strategies adopted for these complications.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients treated with FOCS at the National Center Hospital, National Center of Neurology and Psychiatry, were included.
Key exclusion criteria
When the patient or their family declined to participate in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of neurology
Zip code
187-0025
Address
4-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
ymukuai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of neurology
Zip code
187-0025
Address
4-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
Homepage URL
ymukai@yahoo.co.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of NCNP
Address
4-1-1, Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
Tel
+81-42-341-2712
ymukai@yahoo.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No specific remarks.
Management information
Registered date
| 2025 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067841
