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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022342
Receipt No. R000025741
Scientific Title Neuroprotective evaluation of zonisamide in patients with Parkinson's disease, using dopamine transporter scan (DAT scan)
Date of disclosure of the study information 2016/06/01
Last modified on 2017/08/14

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Basic information
Public title Neuroprotective evaluation of zonisamide in patients with Parkinson's disease, using dopamine transporter scan (DAT scan)
Acronym Evaluation of zonisamide effects by DAT scan in patients with Parkinson's disease
Scientific Title Neuroprotective evaluation of zonisamide in patients with Parkinson's disease, using dopamine transporter scan (DAT scan)
Scientific Title:Acronym Evaluation of zonisamide effects by DAT scan in patients with Parkinson's disease
Region
Japan

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

Objectives
Narrative objectives1 DAT scan is an objective , non-invasively useful test for evaluation of the striatal dopamine metabolic abnormalities. The present study examines the changes of the DAT scan findings after one year in zonisamide-treated and -non-treated patients with Parkinson's disease. The comparative analysis elucidates whether zonisamide can inhibit the death of dopamine neurons.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The specific binding ratio (SBR) on DAT scan at the first (baseline) and second [the mean (SD) of 1.2 (0.2) years later]
Key secondary outcomes UPDRS part II, part III and part IV at the first (baseline) and second [the mean (SD) of 1.2 (0.2) years later]

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 Yale stage II and III in patients with Parkinson' disease
Key exclusion criteria The present study was excluded the following 3 items.
1. Yale stage IV and V in patients with Parkinson' disease.
2. Patients with severe degree of dementia.
3. Patients interrupted zonisamide during the study.
4. Patients with iodine allergy.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Ikeda
Organization Toho University Omori Medical Center
Division name Department of Neurology
Zip code
Address 6-11-1, Omorinishi, Otaku, Tokyo
TEL 03-3762-4151
Email keni@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Ikeda
Organization Toho University Omori Medical Center
Division name Department of Neurology
Zip code
Address 6-11-1, Omorinishi, Otaku, Tokyo
TEL 03-3762-4151
Homepage URL
Email keni@med.toho-u.ac.jp

Sponsor
Institute Department of Neurology, Toho University Omori Medical Center
Institute
Department

Funding Source
Organization Sumitomo Dainippon Pharm 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 東邦大学医療センター大森病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 01 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 1) SBR at endpoint decreased significantly in the non-ZNS group compared to baseline SBR in the non-ZNS group.
2) There were no significant differences between baseline and endpoint SBR in the ZNS group.
3) The change of SBR differed significantly between the ZNS group and the non-ZNS group.
4) The change rate of SBR (%) decreased significantly in the non-ZNS group compared to the ZNS group.
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
2016 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 17 Day
Last follow-up date
2017 Year 07 Month 07 Day
Date of closure to data entry
2017 Year 07 Month 12 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded
2017 Year 08 Month 07 Day

Other
Other related information The patients with levodopa are divided into two groups of zonisamide-treated and non-treated patients. Zonisamide (25 mg/day) is administered at once according to Japanese usage and dose.Second DAT scan is performed in both groups at the mean (SD) of 1.2 (0.2) years after the first DAT scan. Zonisamide is not administered until second time of DAT scan in patients treated without zonisamide. Second DAT scan is performed in the earliest order of patients who underwent the first DAT scan to up to 12 months before the date of approval of the present study. Thus, prescription and non-prescription of zonisamide has been not decided arbitrarily for research purposes, Zonisamide treatment or non-treatment is determined by the appropriate decision based on the diagnosis of each attending physician. Therefore, the physicians who participate in the study can not intervene in the patient division into prescription and non-prescription of zonisamide at the start of the study.

Management information
Registered date
2016 Year 05 Month 18 Day
Last modified on
2017 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025741

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/08/08 UMIN000022342症例データ.docx


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