臨床研究等提出・公開システム

Date of registration	Oct. 05, 2022
Last modified on	May. 22, 2023
Trial ID	jRCT1030220360

Scientific Title	MDS-NMS TRANSLATION PROGRAM FOR NON-ENGLISH OFFICIAL VERSIONS
Public Title	MDS-NMS TRANSLATION PROGRAM

Contact for Scientific Queries	Name	Genko Oyama
	Affiliation	Neurology, Juntendo University
	Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
	Telephone	+81-3-3813-3111
	E-mail	g_oyama@juntendo.ac.jp
Contact for Public Queries	Name	Yoshiyuki Matsuzaki
	Affiliation	Mebix Inc.
	Address	10F. Toranomon 33 Mori Building 3-8-21 Toranomon, Minato-ku, Tokyo
	Telephone	+81-3-4362-4500
	E-mail	MDS-NMS_validation-study@mebix.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 05, 2022
Actual date of first enrollment		June. 08, 2022
Target sample size		300
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients whose native language is Japanese Patients diagnosed with Parkinson's disease according to the International Parkinson and Movement Disorder Society's Parkinson's Disease Diagnostic Criteria 2015 Patients who are able to obtain written consent for participation in the study of their own free will after receiving a thorough explanation of their participation in the study. Patients between the ages of 20 and 79 years old Any gender
	Exclusion Criteria	Patients with serious underlying diseases or complications that make it difficult for the attending physician to make an evaluation decision. Other patients who are deemed inappropriate as research subjects by the principal investigator.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		parkinson's disease
Health Condition(s) Code		D010300
Primary Outcome(s)		Confirmatory factors for the 9 domains of MDS-NMS

Primary Sponsor	Genko Oyama

Source of Monetary Support	International Congress of Parkinsons Disease and Movement Disorders
Secondary Sponsor	Applicable

Name of Certified Review Board	Research Ethics Committee, Faculty of Medicine, Juntendo University
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo, Tokyo, Tokyo
Telephone	+81-3-5802-1584
E-Mail	crbjun@juntendo.ac.jp
Approval Status	Approval
Date of approval	May. 13, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	May. 22, 2023	(this page)	Changes
1	Oct. 05, 2022	Detail

List of change history