UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006521 |
|---|---|
| Receipt number | R000007732 |
| Scientific Title | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease |
| Date of disclosure of the study information | 2011/10/11 |
| Last modified on | 2020/10/19 19:52:02 |
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Basic information
Public title
Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease
Acronym
Switch trial from IR to ER of Pramipexole
Scientific Title
Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease
Scientific Title:Acronym
Switch trial from IR to ER of Pramipexole
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess if Parkinson's disease patients can benefit of nocturnal and early morning symptoms, preference, and convenience by switching from Pramipexole immediate release (IR) to Pramipexole extended release (ER).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preference and convenience for ER
Nocturnal and early morning symptoms
UPDRS part2 and part3 score
Key secondary outcomes
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
Rapid switch of Pramipexole ER (once in a day) which is same dose as IR. The period of administration is 8 weeks.
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
Parkinson's disease patients with nocturnal and early morning symptoms.
Patients doesn't take dopamine agonist except Pramipexole.
Yahr stage is 2-4 at on-phase.
Key exclusion criteria
Patients
take other dopamin agonist
have psychiatric symptoms
have hypotension
have cardiac, renal, and hepatic disease
are pregnant
take the medicine of other clinical trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Takanashi |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
113-8421
Address
2-1-1, Bunkyo, Hongo, Tokyo
TEL
03-3813-3111
nassy-m@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Takanashi |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
113-8421
Address
Department of Neurology
TEL
03-3813-3111
Homepage URL
nassy-m@juntendo.ac.jp
Sponsor or person
Institute
Department of Neurology, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
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
Juntendo Hospital
Address
3-1-3, Hongo, Bunkyo, Tokyo
Tel
03-3813-3111
none
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
| 2011 | Year | 10 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 02 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 11 | Day |
Last modified on
| 2020 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007732
