UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dopamine agonists crossover study
Title of the study (Brief title)	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	Hirofumi Kusaka
Organization	Kansai Medical University
Division name	Neurology
Address	2-5-1 Shinmachi Hirakata
TEL	072-804-2540
Email	kusaka@hirakata.kmu.ac.jp

Public contact
Name of contact person	Satoshi Kaneko
Organization	Kansai Medical University
Division name	Neurology
Address	2-5-1 Shinmachi Hirakata
TEL	072-804-2540
Homepage URL
Email	kanekosa@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002545