UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043283
Receipt No. 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 2021/02/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.