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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024859
Receipt No. R000028608
Scientific Title The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.
Date of disclosure of the study information 2016/11/16
Last modified on 2018/12/12

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Basic information
Public title The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.
Acronym The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.
Scientific Title The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.
Scientific Title:Acronym The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess motor and psychiatric symptoms of Parkinson's disease patients using dopamin agonist and having hallucinations/delusion after swiching from dopamin agonist to zonisamide or reducing dose of dopamin agonist with zonisamide.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in the MDS-UPDRS Part III (motor symptoms) total score at 12 weeks and change in the MDS-UPDRS Part 1.2 (hallucinations and psychosis) score at 12 weeks
Key secondary outcomes 1)Change in the MDS-UPDRS Part1 (non-motor symptoms except Part 1.2) total score, change in the MDS-UPDRS Part 2(motor aspects) total score, and change in the MDS-UPDRS Part 4 (motor complications) total score
2)Change in the BDI-2(depression)total score
3)Change in the JESS(sleepiness)total score
4)Change in the J-ZBI(burden of caregiver) total score
5)Change in the NPI(BPSD) total score
6)Change in the MMSE(cognitive function)total score

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Switching from Dopamine agonist to Zonisamide.

Intervention period of 12 weeks.
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Parkinson's disease patients on a levodopa-containing medication and a dopamine agonist who have hallucinations/delusion(MDS-UPDRS Part 1.2 score>=2)
2)Patients aged 30 years or older at the time of informed consent
3)Patients who have personally given voluntary written informed consent to participation in the study
Key exclusion criteria 1)Patients who have taken zonisamide within 6 months from the start of study drug administration
2)Patients with cognitive impairment of MMSE score 23 or less
3)Patients who have undergone surgical therapy for parkinsonism, including stereotactic neurosurgery
4)Pregnant or possibly pregnant women, women of childbearing potential who do not agree to use appropriate contraceptive measures, or breast-feeding women
5)Patients who, in the opinion of the investigator or other study personnel, are unsuitable for the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Abe
Organization Medical Corporation Abe Neurology Clinic
Division name Neurology
Zip code
Address 6-6 Sakana-machi, Morioka-city,Iwate,020-0878, Japan
TEL 019-606-3711
Email ryuabe@crest.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keigo Nakajima
Organization Sogo Rinsho Medefi Co.,Ltd(Contract Research Organization)
Division name Business Promotion Department
Zip code
Address KDX Shinjuku Bldg. 9F, 3-2-7 Nishi-Shinjuku, Shinjuku-ku Tokyo,160-0023, Japan
TEL 03-6901-6079
Homepage URL
Email TRF@sogo-medefi.jp

Sponsor
Institute Medical Corporation Abe Neurology Clinic
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 16 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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 14 Day
Last follow-up date
2018 Year 08 Month 18 Day
Date of closure to data entry
2018 Year 11 Month 12 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 16 Day
Last modified on
2018 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028608

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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