UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021561 |
|---|---|
| Receipt number | 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 12:08:49 |
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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
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
yshimo@juntendo.ac.jp
Sponsor or person
Institute
Depatment of Neurology
Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024835
