Unique ID issued by UMIN | UMIN000003080 |
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Receipt number | 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 12:23:59 |
Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease
EDP2010 study
Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease
EDP2010 study
Japan |
Parkinson's disease
Neurology |
Others
NO
To investigate the effects of donepezil hydrochloride on motor symptoms and signs of Parkinson's disease
Safety
Exploratory
Explanatory
Not applicable
Changes in UPDRS-3 from the baseline condition
Changes in UPDRS-1, 2, and total UPDRS from the baseline condition
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Donepezil hydrochloride (3mg for 2 weeks, 5mg for 2 weeks)
Placebo
40 | years-old | <= |
75 | years-old | >= |
Male and Female
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.
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.
30
1st name | |
Middle name | |
Last name | Hideyuki Sawada |
Utano National Hospital, National Hospital Organization
Clinical Research Center
8, Ondoyama-cho, Narutaki, Ukyoku, Kyoto
075-461-5121
sawada@unh.hosp.go.jp
1st name | |
Middle name | |
Last name | Hideyuki Sawada |
Utano National Hospital, National Hospital Organization
Clinical Research Center
8 Ondoyamacho, Narutaki, Ukyoku, Kyoto City, Kyoto, Japan
075-461-5121
sawada@unh.hosp.go.jp
Clinical Research Center, Utano National Hospital, National Hospital Organization
National Hospital Organization
Japan
NO
2010 | Year | 01 | Month | 30 | Day |
Unpublished
Terminated
2010 | Year | 01 | Month | 22 | Day |
2010 | Year | 01 | Month | 01 | Day |
2010 | Year | 01 | Month | 24 | Day |
2014 | Year | 01 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003740
Research Plan | |
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Research case data specifications | |
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Registered date | File name |
Research case data | |
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