UMIN-CTR Clinical Trial

Basic information
Public title	Questionnaire survey on proper use methods based on experience of using safinamide
Acronym	Questionnaire survey on proper use methods of safinamide
Scientific Title	Questionnaire survey on proper use methods based on experience of using safinamide
Scientific Title:Acronym	Questionnaire survey on proper use methods of safinamide
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To summarize the doctor's perspectives for the optimal patient type and optimal usage method when using safinamide for patient with Parkinson's disease and wearing off.
Basic objectives2	Others
Basic objectives -Others	Non-intervention, cross-sectional studies, questionnaire surveys
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The following items are evaluated on a four-point scale: 1 (disagree), 2 (somewhat disagree), 3 (somewhat agree), and 4 (agree). For some questions, the perspective of the subjects will be evaluated by alternative answer or free description. 1) Patietn types in which safinamide should be used from the viewpoints of motor symptoms, motor complications, non-motor symptoms, treatment history, etc. associated with Parkinson's disease 2) Patient types in which safinamide should be withheld, reduced dose or discontinued 3) Use method when dyskinesia appears while using safinamide, optimal safinamide use method for the elderly, and patient types where it is recommended to increase the safinamide dose to a high dose. 4) Demographic profiles of subjects
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	Subjects must satisfy all of the follwing criteria. [Selection criteria in the 1st Questionnaire Survey] 1)Doctors who fully understands the research and have consent to participate in this survey on the website. 2) Doctors over 30 years old 3) Doctors with more than 5 years of experience in treating Parkinson's disease 4) Doctors with 10 or more patients with Parkinson's disease who are continuously treated 5) Doctors with one or more patients who have prescribed safinamide [Selection criteria in the 2nd Questionnaire Survey] 1) Doctors who fully understands the research and have consent to participate in this survey on the website. 2) Doctors over 30 years old 3) Doctors with more than 5 years of experience in treating Parkinson's disease 4) Doctors with 10 or more patients with Parkinson's disease who are continuously treated 5) Doctors who have prescribed safinamide for 5 or more patients and have been using it for 3 months or more
Key exclusion criteria	[Exclusion criteria in the 1st Questionnaire Survey] 1) Doctors who cannot fill out and answer questionnaires by themselves 2) Doctors who did not complete the answers to all the questionnaires [Exclusion criteria in the 2nd Questionnaire Survey] 1) Doctors who cannot fill out and answer questionnaires by themselves 2) Doctors who did not complete the answers to all the questionnaires 3) Doctors who are judged by the principal investigator / coordinator to be inappropriate for the results of this study
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Takeda
Organization	National hospital organization sendai nishitaga national hospital
Division name	Department of Neurology
Zip code	982-8555
Address	2-11-11 Kagitorihoncho, Taihaku-ku, Sendai, 982-8555
TEL	022-245-2111
Email	takeda.atsushi.nc@mail.hosp.go.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Ishida
Organization	Eisai Co., Ltd.
Division name	Medical HQs
Zip code	162-0812
Address	Sumitomo Fudosan Iidabashi building No.3, Nishigoken-cho 13-1, Shinjuku-ku, Tokyo
TEL	03-5228-7112
Homepage URL
Email	t8-ishida@hhc.eisai.co.jp

Sponsor
Institute	National hospital organization sendai nishitaga national hospital, Eisai Co., Ltd.
Institute
Department

Funding Source
Organization	Eisai Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Takahashi Clinic Ethics Committee
Address	5-1-31 , Iwayakita-machi ,Nada-ku, Kobe City, Hyogo,
Tel	078-882-6432
Email	kishimoto.satoshi@neues.co.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	株式会社QLife

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 02 Month 07 Day
Date of IRB	2021 Year 02 Month 16 Day
Anticipated trial start date	2021 Year 02 Month 19 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study was conducted as a questionnaire survey on the doctor panel of M3 Co., Ltd. via the web. The collected answers to the questionnaire will be anonymized and individuals will not be identified.

Management information
Registered date	2021 Year 02 Month 09 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049414

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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