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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: Shimizu Yoshitaka
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
Countries of recruitment
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
Secondary Sponsor(s)
Ethics review
Status: Approval
Approval date:
Contact:
Tokushukai Group Institutional Review Board
+81-3-3263-4801
Results
Results available:
Date Posted:
Date Completed:
URL:
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