UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044341 |
|---|---|
| Receipt number | R000050610 |
| Scientific Title | Observational study of Safinamide as add-on to levodopa monotherapy for Parkinson's disease patients with wearing-off in Japan |
| Date of disclosure of the study information | 2021/05/28 |
| Last modified on | 2023/08/03 14:59:51 |
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Basic information
Public title
Observational study of Safinamide as add-on to levodopa monotherapy for Parkinson's disease patients with wearing-off in Japan
Acronym
J-SILVER study
Scientific Title
Observational study of Safinamide as add-on to levodopa monotherapy for Parkinson's disease patients with wearing-off in Japan
Scientific Title:Acronym
J-SILVER study
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find the efficacy and safety of safinamide as first add-on treatment in Parkinson's disease patients with wearing off who are receiving oral levodopa-containing formulation only.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
<Parkinson's disease symptom assessment>
Patient diary (Off time, On time)
MDS-UPDRS(MDS-Unified Parkinson's Disease Rating Scale) part I, III, IV
<QOL assessment>
PDQ-39(Parkinson's disease questionnaire-39)
<Overall improvement assessment>
CGI-I(Clinical Global Impression-Improvement)
PGI-I(Patient Global Impression-Improvement)
<Pain assessment>
NRS(Numerical Rating Scale)
KPPS(King's Parkinson's Disease Pain Scale)
<Actigraph assessment>
Body movement, Energy consumption, Strength-related indicators, Walking, Sleep
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
(1)Patients who have fully understood the research contents and voluntarily provided a written informed consent to participate in this study.
(2)Patients over 20 years old at the time of informed consent. (No upper age limit.)
(3)Patients diagnosed
with Parkinson's disease based on the International Parkinson and Movement Disorder Society (MDS) diagnostic criteria (2015)
(4)Patients who are
using oral levodopa-containing formulation(excluding levodopa/carbidopa hydrate/entacapone combination drug) and have a predictable wearing-off phenomenon at the time of disappearance of drug efficacy, and whose effects of monotherapy with levodopa-containing formulation
are insufficient.
(5)Patients who will receive combination therapy with safinamide.
(6)Be able to record patient diary for 4 days or more of the last 7 days at baseline (week 0)
Key exclusion criteria
(1)Patients who received treatment with antiparkinsonian drugs other than oral levodopa-containing formulation within 4 weeks prior to baseline (week 0).
(2)Patients who are planning brain surgery (destructive surgery, deep brain stimulation, etc.)
for Parkinson's disease
(3)Patients with severe
liver dysfunction (Child-Pugh classification C)
(4)Patients with a history
of hypersensitivity to safinamide components
(5)Patients with
psychiatric disorders that may affect performance of scheduled examination.
(6)Patients who are pregnant or may be pregnant.
(7)Patients who principal investigator / coordinator have judged inappropriate to participate in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Nishikawa |
Organization
Juntendo University Hospital
Division name
Department of Neurology
Zip code
113-8421
Address
Hongo3-1-3,Bunkyo-ku,Tokyo, 113-8421 Japan
TEL
03-3813-3111
n.nishikawa.ts@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomohito |
| Middle name | |
| Last name | Ide |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Division
Zip code
103-0027
Address
14-1 Nihonbashi2-chome, Chuo-ku, Tokyo, 103-0027 Japan
TEL
03-6386-8800
Homepage URL
J-SILVER@apoplus.co.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Eisai Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital Ethics Committee
Address
Hongo3-1-3,Bunkyo-ku,Tokyo, 113-8431 Japan
Tel
03-3814-5672
kenkyu5858@juntendo.ac.jp
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
順天堂大学医学部附属浦安病院(千葉県)、順天堂大学医学部附属順天堂越谷病院(埼玉県)、順天堂大学医学部附属順天堂東京江東高齢者医療センター(東京都)、順天堂大学医学部附属練馬病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 19 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
Prospective observational study
Patients who visited our facility and met the selection criteria and obtained their consent by July 31, 2022 after the approval of the Ethics Committee.
Management information
Registered date
| 2021 | Year | 05 | Month | 26 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050610
| Research Plan | |
|---|---|
| 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 |
