UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043283
Receipt number R000049414
Scientific Title Questionnaire survey on proper use methods based on experience of using safinamide
Date of disclosure of the study information 2021/02/17
Last modified on 2022/07/19 09:50:03

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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 or person

Institute

National hospital organization sendai nishitaga national hospital,
Eisai Co., Ltd.

Institute

Department

Personal name



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

https://doi.org/10.1155/2022/3203212

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1155/2022/3203212

Number of participants that the trial has enrolled

150

Results

As published in the paper.

Results date posted

2022 Year 07 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

As published in the paper.

Participant flow

As published in the paper.

Adverse events

As published in the paper.

Outcome measures

As published in the paper.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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 22 Day

Last follow-up date

2021 Year 06 Month 10 Day

Date of closure to data entry

2021 Year 08 Month 10 Day

Date trial data considered complete

2021 Year 08 Month 10 Day

Date analysis concluded

2021 Year 08 Month 10 Day


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

2022 Year 07 Month 19 Day



Link to view the page

Value
https://center6.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