UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013161 |
|---|---|
| Receipt number | 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 09:49:04 |
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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
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
nhattori@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015346
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
