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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021561
Receipt No. R000024835
Scientific Title Efficacy of IPX066 for Japanese Parkinson's disease patients. Open trial
Date of disclosure of the study information 2016/05/01
Last modified on 2019/06/03

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Basic information
Public title Efficacy of IPX066 for Japanese Parkinson's disease patients. Open trial
Acronym IPX066 for Japanese PD patients.
Scientific Title Efficacy of IPX066 for Japanese Parkinson's disease patients. Open trial
Scientific Title:Acronym IPX066 for Japanese PD patients.
Region
Japan

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

Objectives
Narrative objectives1 To see the effect of Rytary for Japanese PD patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the change of on and off time percentage while awake,
Key secondary outcomes UPDRS motor score

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 2 years application of Rytary with 95 mg/23.75 mg or 145 mg/36.25 mg or 195 mg/48.75 mg or 245 mg/61.25 mg
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Parkinson's disease patients
Key exclusion criteria Patients with parkinson syndrome
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Shimo
Organization Juntendo University School of Medicine
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-3813-3111
Email yshimo@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Shimo
Organization Juntendo University School of Medicine
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-3813-3111
Homepage URL
Email yshimo@juntendo.ac.jp

Sponsor
Institute Depatment of Neurology
Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Depatment of Neurology
Juntendo University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 05 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 Terminated
Date of protocol fixation
2016 Year 03 Month 18 Day
Date of IRB
2016 Year 03 Month 18 Day
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2019 Year 06 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 22 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024835

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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