UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022342
Receipt number 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 22:03:48

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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 or person

Institute

Department of Neurology, Toho University Omori Medical Center

Institute

Department

Personal name



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

Value
https://center6.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