UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026890 |
|---|---|
| Receipt number | R000030839 |
| Scientific Title | The pharmacoepidemiological study of Zonisamide for Parkinson's disease |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2019/10/07 10:02:32 |
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Basic information
Public title
The pharmacoepidemiological study of Zonisamide for Parkinson's disease
Acronym
The pharmacoepidemiological study of Zonisamide for Parkinson's disease
Scientific Title
The pharmacoepidemiological study of Zonisamide for Parkinson's disease
Scientific Title:Acronym
The pharmacoepidemiological study of Zonisamide for Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the association between zonisamide prescription and the disease status of Parkinson's disease, concomitant disease,and other prescriptions, using commercial base receipt data. We will also investigate the association between zonisamide prescription and other anti-Parkinson drugs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
The incidence and prevalence of comorbidities
Key secondary outcomes
The doses of anti-Parkinson drugs.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed with Parkinson's disease (ICD-10:G20) between April 2008 to December 2012.
Key exclusion criteria
1. Having only sub-category of G20; 3320001, 8830558, 8841415.
2. Secandary Parkinson's diseaase, which is defined as diagnosed with ICD-10 codes of G21, G22, and G23.
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Iwaki |
Organization
Ehime University Graduate School of Medicine
Division name
Neurology and Clinical Pharmacology
Zip code
791-0295
Address
Shitsugawa 454, Toon, Ehime, Japan. ZIP 7910295
TEL
089-960-5095
h-iwaki@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Iwaki |
Organization
Ehime University Graduate School of Medicine
Division name
Neurology and Clinical Pharmacology
Zip code
791-0295
Address
Shitsugawa 454, Toon, Ehime, Japan. ZIP 7910295
TEL
089-960-5095
Homepage URL
h-iwaki@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sumitomo Dainippon Pharma Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.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
愛媛大学病院、大日本住友製薬株式会社・メディカルアフェアーズ部
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.jns.2019.05.028
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jns.2019.05.028
Number of participants that the trial has enrolled
9157
Results
The zonisamide use was significantly associated with a lower risk of dementia, insomnia, and gastric ulcers than 3 of 7 other classes without levodopa (p<.05).
Results date posted
| 2019 | Year | 10 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This was a cohort study based on claims data from Diagnosis Procedure Combination hospitals between 2008 and 2014 in Japan. Patients were included in the cohort if they were diagnosed with PD, aged >=40 years, and were prescribed anti-PD drugs from the same single class without switching to/combination use with other classes excepting levodopa.
Participant flow
In the final cohort, 9157 patients were included.
Adverse events
None.
Outcome measures
The outcomes were the incidence of PD-relevant symptoms from the following categories; mental/psychiatric, autonomic nervous system, motor-related, and gastric symptoms. The associations between the incidence of these symptoms and the prescriptions of 8 different classes of anti-PD drugs were explored by the survival analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 04 | Month | 06 | Day |
Last modified on
| 2019 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030839
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| Registered date | File name |
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