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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003080
Receipt No. R000003740
Scientific Title Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease
Date of disclosure of the study information 2010/01/30
Last modified on 2014/01/24

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Basic information
Public title Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease
Acronym EDP2010 study
Scientific Title Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease
Scientific Title:Acronym EDP2010 study
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effects of donepezil hydrochloride on motor symptoms and signs of Parkinson's disease
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in UPDRS-3 from the baseline condition
Key secondary outcomes Changes in UPDRS-1, 2, and total UPDRS from the baseline condition

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Donepezil hydrochloride (3mg for 2 weeks, 5mg for 2 weeks)
Interventions/Control_2 Placebo
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
40 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) UK brain bank Parkinson's disease diagnostic criteria (steps 1 and 2)
2) Hoehn-Yahr stages (I to III)
3) Not taking donepezil hydrochloride or other AchE inhibitors in the preceding 4 weeks.
4) Subjects who gave the written informed consent.
Key exclusion criteria 1) Subjects taking anti-cholinergic drugs, including trihexyphenidyl, biperidien, profenamine, piroheptine, metixene, mazaticol, promethazine, cyproheptadine.
2) Subjects with diffuse Lewy body disease (according to third report of the DLB consortium) .
3) Present or previous diagnosis of schizophrenia.
4) Severe liver dysfunction or severe renal dysfuction.
5) Present or previous diagnosis of sick sinus syndrome
6) Present or previous diagnosis of broncheal asthma.
7) Subjects who investigators judge as inappropriate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Sawada
Organization Utano National Hospital, National Hospital Organization
Division name Clinical Research Center
Zip code
Address 8, Ondoyama-cho, Narutaki, Ukyoku, Kyoto
TEL 075-461-5121
Email sawada@unh.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Sawada
Organization Utano National Hospital, National Hospital Organization
Division name Clinical Research Center
Zip code
Address 8 Ondoyamacho, Narutaki, Ukyoku, Kyoto City, Kyoto, Japan
TEL 075-461-5121
Homepage URL
Email sawada@unh.hosp.go.jp

Sponsor
Institute Clinical Research Center, Utano National Hospital, National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 30 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
2010 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 24 Day
Last modified on
2014 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003740

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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