UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024859
Receipt number R000028608
Scientific Title Effectiveness of switching from dopamine agonists to zonisamide or combining with zonisamide on psychiatric and motor symptoms in patients with Parkinson's disease
Date of disclosure of the study information 2016/11/16
Last modified on 2022/02/01 13:58:25

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Basic information

Public title

Effectiveness of switching from dopamine agonists to zonisamide or combining with zonisamide on psychiatric and motor symptoms in patients with Parkinson's disease

Acronym

Effectiveness of switching from dopamine agonists to zonisamide or combining with zonisamide on psychiatric and motor symptoms in patients with Parkinson's disease

Scientific Title

Effectiveness of switching from dopamine agonists to zonisamide or combining with zonisamide on psychiatric and motor symptoms in patients with Parkinson's disease

Scientific Title:Acronym

Effectiveness of switching from dopamine agonists to zonisamide or combining with zonisamide on psychiatric and motor symptoms 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

Evaluation the effectiveness of reducing or discontinuing dopamine agonists (DAs) and adding zonisamide on motor and psychiatric symptoms in patients with Parkinson's disease who taking levodopa and had hallucinations and/or delusions considered to be attributed to use of DAs.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 (motor symptoms) and MDS-UPDRS Part 1.2 (hallucinations and psychosis) scores after 12 weeks from baseline

Key secondary outcomes

1) Changes in the MDS-UPDRS Part 1 (non-motor symptoms except Part 1.2) , MDS-UPDRS Part 2 (motor aspects), and MDS-UPDRS Part 4 (motor complications) scores from baseline
2) Change in the Beck Depression Inventory-II (BDI-II, depression) score from baseline
3) Change in the Japanese version of the Epworth Sleepiness Scale (JESS, sleepiness) total score from baseline
4) Change in the Mini-Mental State Examination (MMSE, cognitive function) score from baseline


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

ļ½„Reducing or discontinuing DAs and adding zonisamide.
ļ½„Intervention period: 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)Patients with Parkinson's disease who taking a levodopa-containing medication and DAs, and have hallucinations and/or delusions (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 the study
2)Patients with cognitive impairment (MMSE score =< 23)
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 Takashi
Middle name
Last name Abe

Organization

Medical Corporation Abe Neurology Clinic

Division name

Neurology

Zip code

020-0878

Address

6-6 Sakana-machi, Morioka-city,Iwate, Japan

TEL

019-606-3711

Email

ryuabe@crest.ocn.ne.jp


Public contact

Name of contact person

1st name Keigo
Middle name
Last name Nakajima

Organization

EP-CRSU Co. Ltd.

Division name

Clinical Business Operation Headquarters Clinical Research Management Center

Zip code

162-0814

Address

Acropolis TOKYO Bldg. 3F, 6-29 Shinogawamachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5684-7809

Homepage URL


Email

TRF@eps.co.jp


Sponsor or person

Institute

Medical Corporation Abe Neurology Clinic

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Joint Ethical Review Board

Address

Sanyokochi Bld.3F, 1-14 Minamikubo, Kochi-shi, Kochi, 781-0087, Japan

Tel

042-648-5551

Email

godou-irb@eps.co.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



Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.neurology-jp.org/Journal/public_pdf/061070449.pdf

Number of participants that the trial has enrolled

11

Results

MDS-UPDRS Part 3, and Part 1.2 scores at week 12 were significantly lower than those at the baseline.

Results date posted

2022 Year 02 Month 01 Day

Results Delayed

Delay expected

Results Delay Reason

Results delayed because additional analysis was performed to discuss the results of this study.

Date of the first journal publication of results

2021 Year 07 Month 01 Day

Baseline Characteristics

The baseline characteristics of the 11 participants were as follows:
All participants were treated with zonisamide 25 mg. The age was 73.5 +- 8.1 years old (mean +- SD), ten of them were over 65 years old. One participant was a male.
The duration of Parkinson's disease was 8.0 +- 6.3 years, the score of the MDS-UPDRS Part 1.2 and Part 3 at baseline were 2.7 +- 0.5 and 31.5 +- 7.2, respectively.
The dose-reduced or discontinued DAs were as follows: ropinirole hydrochloride: 7 patients, rotigotine: 3 patients, pramipexole: 1 patient. After 12 weeks, 5 patients discontinued DAs and 6 patients reduced their dose of DAs.
About the status of the usage of concomitant antiparkinsonian drugs except for levodopa and DAs, 2 participants were treated with entacapone, 2 were treated with istradefylline and 1 was treated with selegiline hydrochloride.

Participant flow

Eleven patients were registered in this study. All participants were completed the study; therefore, all participants were included to "Full analysis set".

Adverse events

One adverse event (Bronchitis: no causal relationship to the study drugs) was observed. No severe adverse event or discontinuation of zonisamide administration was observed.

Outcome measures

Primary endpoint:
The changes in the MDS-UPDRS Part 1.2 and Part 3 scores after 12 weeks from baseline were -2.4 +- 0.2 and -5.1 +- 0.9 (least squares mean +- standard error), respectively, with the score reductions being statistically significant.

Secondary endpoint:
The scores of the MDS-UPDRS Part 1, Part 1 (excluding Part 1.2) after 12 weeks were significantly lower than the baseline scores. On the other hand, the scores of MDS-UPDRS Part 2, Part 4, BDI-II, JESS and MMSE at week 12 showed no significant change from the baseline, respectively.

Plan to share IPD

No

IPD sharing Plan description

No


Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 08 Month 23 Day

Date of IRB

2016 Year 09 Month 16 Day

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

2018 Year 11 Month 22 Day

Date analysis concluded

2020 Year 02 Month 20 Day


Other

Other related information

An additional analysis was performed to discuss the research results (without changing research objectives).
The Ethics Review Committee approved to perform the additional analysis.


Management information

Registered date

2016 Year 11 Month 16 Day

Last modified on

2022 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028608


Research Plan
Registered date File name

Research case data specifications
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Research case data
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