UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002163 |
|---|---|
| Receipt number | R000002545 |
| Scientific Title | Dopamine agonists crossover study |
| Date of disclosure of the study information | 2009/07/07 |
| Last modified on | 2017/05/21 15:39:50 |
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Basic information
Public title
Dopamine agonists crossover study
Acronym
DACS
Scientific Title
Dopamine agonists crossover study
Scientific Title:Acronym
DACS
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate effects of two non-ergot dopamine agonists, pramilexole(PPX) and ropinirole(ROP), on motor/non-motor functions and biochemical laboratory tests of Parkinson's disease patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MDS-UPDRS, ESS(Epworth Sleepiness Scale), SHAPS(Snaith-Hamilton Pleasure Scale). Biochemical laboratory tests.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Overnight switch from PPX to
ROP at dose ratio 3:10. Evaluation at 0, 2, 4, 8 weeks.
Interventions/Control_2
Overnight switch from ROP to
PPX at dose ratio 10:3. Evaluation at 0, 2, 4, 8 weeks.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatient Parkinson's disease patients whose clinical symptoms are well medically controlled.
Key exclusion criteria
Those who cannot give an effective informed consent.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kusaka |
Organization
Kansai Medical University
Division name
Neurology
Zip code
Address
2-5-1 Shinmachi Hirakata
TEL
072-804-2540
kusaka@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kaneko |
Organization
Kansai Medical University
Division name
Neurology
Zip code
Address
2-5-1 Shinmachi Hirakata
TEL
072-804-2540
Homepage URL
kanekosa@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 07 | 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
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 03 | Day |
Last modified on
| 2017 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002545
