臨床研究等提出・公開システム

Date of registration	May. 13, 2021
Last modified on	May. 17, 2022
Trial ID	jRCT2031210089

Scientific Title	A phase II clinical study of KDT-3594 in Japanese patients with early Parkinson's disease.
Public Title	A clinical study of KDT-3594 in Japanese patients with early Parkinson's disease.

Contact for Scientific Queries	Name	Shimizu Yoshitaka
	Affiliation	Kissei Pharmaceutical Co., Ltd.
	Address	3-1-3, Koishikawa, Bunkyo, Tokyo, 112-0002, Japan
	Telephone	+81-120-007-622
	E-mail	rinsyousiken@pharm.kissei.co.jp
Contact for Public Queries	Name	Shimizu Yoshitaka
	Affiliation	Kissei Pharmaceutical Co., Ltd.
	Address	3-1-3, Koishikawa, Bunkyo, Tokyo, 112-0002, Japan
	Telephone	+81-120-007-622
	E-mail	rinsyousiken@pharm.kissei.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 01, 2021
Actual date of first enrollment		May. 15, 2021
Target sample size		6
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
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 over
	Age Maximum	80age old not
	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)

Primary Sponsor	Kissei Pharmaceutical Co., Ltd.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Tokushukai Group Institutional Review Board
Address	1-8-7, Kojimachi, Chiyoda, Tokyo
Telephone	+81-3-3263-4801
Approval Status	Approval
Date of approval	April. 21, 2021

Plan to share IPD	No

Secondary ID(s)	NCT04867551
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	May. 17, 2022	(this page)	Changes
4	Mar. 17, 2022	Detail	Changes
3	Sept. 02, 2021	Detail	Changes
2	May. 21, 2021	Detail	Changes
1	May. 13, 2021	Detail

List of change history