UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045364 |
|---|---|
| Receipt number | R000051778 |
| Scientific Title | Examination of the Effect of Istradefylline on Postural Abnormalities in Parkinson's Disease Based on Photo Data (Retrospective study) |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2024/03/13 16:29:53 |
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Basic information
Public title
Examination of the Effect of Istradefylline on Postural Abnormalities in Parkinson's Disease Based on Photo Data (Retrospective study)
Acronym
Postural Abnormalities in Parkinson's Disease
Scientific Title
Examination of the Effect of Istradefylline on Postural Abnormalities in Parkinson's Disease Based on Photo Data (Retrospective study)
Scientific Title:Acronym
Postural Abnormalities in Parkinson's Disease
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the clinical effect of istradefylline on postural abnormalities in Parkinson's disease from photo data
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between severity of postural abnormalities based on angle data prior to isradefylline treatment and changes in UDRS score before and after istradefylline treatment.
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 have already obtained written consent for the previous study (jRCTs051180185)
Patient whose angle data from photo has already been acquired
Key exclusion criteria
NA
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Makio |
| Middle name | |
| Last name | Takahashi |
Organization
Kansai Medical University
Division name
Department of Neurodegenerative Disorders
Zip code
573-1191
Address
2-5-1 Shin-machi, Hirakata City, Osaka
TEL
072-804-0101
ta@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Makio |
| Middle name | |
| Last name | Takahashi |
Organization
Kansai Medical University
Division name
Department of Neurodegenerative Disorders
Zip code
573-1191
Address
2-5-1 Shin-machi, Hirakata City, Osaka
TEL
072-804-0101
Homepage URL
ta@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kitano Hospital, The Tazuke-Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Wakayama Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Kitano Hospital
Address
2-4-20 Ohgimachi, Kita-Ku, Osaka
Tel
06-6131-2792
rinshou@kitano-hp.or.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
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Not open to the public
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/ S2405650223000515?via%3Dihub
Number of participants that the trial has enrolled
31
Results
Patients with more advanced postural abnormalites showed more consistent improvements in the UDRS total score with istradefylline.
Results date posted
| 2024 | Year | 03 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 30 | Day |
Baseline Characteristics
Age, years 73.3 (7.7)
Female, n (%) 18 (58.1)
Body weight, kg 49.4 (9.6)
Duration of PD, years 6.2 (4.2)
Duration of motor complications, years 3.2 (4.4)
MMSE score 27.4 (2.1)
UDRS score 15.2 (3.7)
mH&Y score (on state) 2.4 (0.6)
mH&Y score (off state) 4.1 (1.1)
Participant flow
31 patients were enrolled and 24 completed the study. Overall, 7 patients discontinued the study: 3 due to AEs, 2 due to withdrawal of consent, and 2 based on the physician's decision.
Adverse events
Refer to the previous study (Takahashi et al., J Neurol Sci, 2022)
Outcome measures
The change and percent change in the UDRS total score from week 0 to week 24 of istradefylline treatment.
Plan to share IPD
No shared plan
IPD sharing Plan description
No shared plan
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 30 | Day |
Other
Other related information
This study is a retrospective study of clinical study (intervention study) (jRCTs051180185) for postural abnormalities in Parkinson's disease patients.
Management information
Registered date
| 2021 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051778
