UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026890
Receipt No. 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 (Ver. 5)

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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
Email 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
Email h-iwaki@m.ehime-u.ac.jp

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030839