UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005403 |
|---|---|
| Receipt number | R000003883 |
| Scientific Title | A Multi-center Randomized Placebo-controlled Double-blinded Study for the Efficacy of Donepezil against Psychosis in Parkinson Disease |
| Date of disclosure of the study information | 2011/04/08 |
| Last modified on | 2018/08/06 19:29:43 |
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Basic information
Public title
A Multi-center Randomized Placebo-controlled Double-blinded Study for the Efficacy of Donepezil against Psychosis in Parkinson Disease
Acronym
EDAP study
Scientific Title
A Multi-center Randomized Placebo-controlled Double-blinded Study for the Efficacy of Donepezil against Psychosis in Parkinson Disease
Scientific Title:Acronym
EDAP study
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy of donepezil hydrochloride concerning prevention of psychosis in Parkinson disease patients who have no psychosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Time to the occurence of psychosis
Key secondary outcomes
Other outcomes that are defined in the study protocol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
5mg of donepezil hydrochloride
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) UK brain bank Parkinson's disease diagnostic criteria (steps 1 and 2)
2) modified Hoehn-Yahr stages (2.5, III, IV)
3) Previous history of hallucinations, delirium, or dlusions
4) Not taking donepezil hydrochloride or other AchE inhibitors in the preceding 4 weeks.
5) Subjects who gave the written informed consent.
Key exclusion criteria
1. Past use of donepezil hydrochloride.
2. Use of an inhibitor of brain acetylcholine esterase (listed in the protocol) in the 4 weeks before Visit 2.
3. Use of Yoku-Kan-San in the 4 weeks before Visit 4.
4. Use of anti-psychotic drugs (listed in the protocol) in the 12 weeks before Visit 2.
5. Patients who are diagnosed as possible or probable diffuse Lewy body disease according to the diagnostic criteria (shown in the protocol).
6. Patients who have been diagnosed as schizophrenia
7. Patients with previous history of the stereotaxic brain operation
8. Patients with allergy to pyperidium derivatives.
9. Severe hepatic or renal dysfunction (Grade 3 in the protocol).
10. Patients with sick sinus syndrome or intra-atrial or AV nodal block (such as SA block or AV block of grade II or severer).
11. Patients with present or previous illness of severe gastrointestinal ulcer, severe bronchial asthma, or obstructive pulmonary disease.
12. Bradycardia (heart rate: 45 /min or less.) in the ECG at Visit 1.
13. QT elongation (QTc: >460msec) in the ECG at Visit 1.
14. Patients who are pregnant or feeding a baby.
15. Patients who participated in the other clinical trial in the 12 weeks before Visit 2.
16. Patients who are diagnosed as having malignancy
17. Patients who are judged as inappropriate for the enrolling to the trial by investigators.
Target sample size
142
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 Ondoyamacho, Narutaki, Ukyoku, Kyoto
TEL
81-75-461-5121
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
TEL
81-75-461-5121
Homepage URL
sawada@unh.hosp.go.jp
Sponsor or person
Institute
Designated Research, National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
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
国立病院機構北海道医療センター、国立病院機構相模原病院、国立病院機構静岡てんかん神経医療センター、 国立病院機構宇多野病院、国立病院機構京都医療センター、国立病院機構南京都病院、国立病院機構刀根山病院、国立病院機構長崎川棚医療センター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
http://bmjopen.bmj.com/content/3/9/e003533.full
Publication of results
Published
Result
URL related to results and publications
https://jnnp.bmj.com/content/early/2018/08/03/jnnp-2018-318107
Number of participants that the trial has enrolled
Results
[Results] Kaplan-Meier curves for psychosis development were very similar between the two groups and the Cox proportional hazard model revealed an adjusted hazard ratio of 0.87 (95% confidence interval 0.48-1.60). The changes in MMSE and WMS-1 (auditory memory) were significantly better with donepezil than in placebo. In the subgroup analysis, donepezil provided a hazard ratio of 0.31 (0.11-0.86) against psychosis in 48 weeks for apolipoprotein e4 non-carriers.
[Conclusions] Although donepezil provided beneficial effects on PPQ, MMSE and auditory WMS score changes in two years, it had no prophylactic effect on development of psychosis in PD. Apolipoprotein e4 may suppress the anti-psychotic effect of donepezil.
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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 08 | Day |
Last modified on
| 2018 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003883
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
