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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013161
Receipt No. R000015346
Scientific Title japan-first-in large scale observational study for non-motor symptoms and treatment in parkinson's disease patients
Date of disclosure of the study information 2014/03/01
Last modified on 2018/08/22

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Basic information
Public title japan-first-in large scale observational study for non-motor symptoms and treatment in parkinson's disease patients
Acronym observational study for non-motor symptoms and treatment in parkinson's disease patients
Scientific Title japan-first-in large scale observational study for non-motor symptoms and treatment in parkinson's disease patients
Scientific Title:Acronym observational study for non-motor symptoms and treatment in parkinson's disease patients
Region
Japan

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

Objectives
Narrative objectives1 The objectives of this study are to identify factors having an impact on non-motor symptoms or QOL in PD patients (e.g., patient characteristics, complications, previous illness, or treatment) and to evaluate the effects of istradefylline on non-motor symptoms and QOL.
Basic objectives2 Others
Basic objectives -Others Improvement or changing of MDS-UPDRS and PDQ-8 score.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I
Parkinson's Disease Questionire-8 (PDQ-8)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients who have wearing off under treatment with levodopa-containing drugs administered at least three times daily
(2)Patients who have at least one non-motor symptom as a complication
(3)Patients at least 20 years of age at the time of consent
(4)Patients who have given written consent
If the patient has difficulty in writing due to his or her condition, the legally acceptable representative may sign the written consent, subject to the patient's prior oral consent.
(5)Patients who are receiving outpatient care
Key exclusion criteria (1)Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE)
(2)Patients, in the opinion of the investigator or subinvestigator, having conditions impairing the proper assessment of the MDS-UPDRS or PDQ-8 (e.g., patients who are receiving treatment for malignant tumor)
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobutaka Hattori
Organization Juntendo University
Division name Neurology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, JAPAN
TEL 03-3813-3111
Email nhattori@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobutaka Hattori
Organization Juntendo University
Division name Neurology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, JAPAN
TEL 03-3813-3111
Homepage URL
Email nhattori@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Kyowa Hakko Kirin Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02073981
Org. issuing International ID_1 Clinical Trials gov.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 01 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 Completed
Date of protocol fixation
2013 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2016 Year 04 Month 18 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
2016 Year 08 Month 25 Day
Date analysis concluded

Other
Other related information Improvement or changing of MDS-UPDRS and PDQ-8 score.

Management information
Registered date
2014 Year 02 Month 14 Day
Last modified on
2018 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015346

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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