Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
JPRN |
Last refreshed on:
|
17 October 2023 |
Main ID: |
JPRN-jRCT2031210089 |
Date of registration:
|
13/05/2021 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A clinical study of KDT-3594 in Japanese patients with early Parkinson's disease.
|
Scientific title:
|
A phase II clinical study of KDT-3594 in Japanese patients with early Parkinson's disease. |
Date of first enrolment:
|
15/05/2021 |
Target sample size:
|
6 |
Recruitment status: |
Complete |
URL:
|
https://jrct.niph.go.jp/latest-detail/jRCT2031210089 |
Study type:
|
Interventional |
Study design:
|
single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
|
Phase:
|
2
|
|
Contacts
|
Name:
|
Yoshitaka
Shimizu |
Address:
|
3-1-3, Koishikawa, Bunkyo, Tokyo, 112-0002, Japan
112-0002
Tokyo
Japan |
Telephone:
|
+81-120-007-622 |
Email:
|
rinsyousiken@pharm.kissei.co.jp |
Affiliation:
|
Kissei Pharmaceutical Co., Ltd. |
|
Name:
|
Yoshitaka
Shimizu |
Address:
|
3-1-3, Koishikawa, Bunkyo, Tokyo, 112-0002, Japan
112-0002
Tokyo
Japan |
Telephone:
|
+81-120-007-622 |
Email:
|
rinsyousiken@pharm.kissei.co.jp |
Affiliation:
|
Kissei Pharmaceutical Co., Ltd. |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: -Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria -Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
Exclusion criteria: -Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease. -Patients who underwent neurosurgical medical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study -Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score < 24 points
Age minimum:
>= 20age old
Age maximum:
< 80age old
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Parkinson's disease
|
Intervention(s)
|
Oral and titrated doses of KDT-3594
|
Primary Outcome(s)
|
-Occurrence of adverse events -Plasma concentrations of KDT-3594 and its metabolites
|
Secondary Outcome(s)
|
-Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
|
Secondary ID(s)
|
NCT04867551
|
Source(s) of Monetary Support
|
Ethics review
|
Status: Approval
Approval date:
Contact:
Tokushukai Group Institutional Review Board
+81-3-3263-4801
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|