UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044246
Receipt number R000050531
Scientific Title An open-label, unblinded, exploratory study to evaluate the eye movement in Parkinson disease patients
Date of disclosure of the study information 2021/05/18
Last modified on 2023/07/05 17:05:12

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Basic information

Public title

An exploratory study to evaluate the eye movement in Parkinson disease

Acronym

ExSEM-PD

Scientific Title

An open-label, unblinded, exploratory study to evaluate the eye movement in Parkinson disease patients

Scientific Title:Acronym

ExSEM-PD

Region

Japan


Condition

Condition

Parkinson disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is to investigate the correlation between eye movement, clinical evaluation scales and plasma levodopa concentration during administration of levodopa in Parkinson's disease patients.

Basic objectives2

Others

Basic objectives -Others

Pathophysiology

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

1. Clinical evaluation scales for Parkinson disease (Hoehn-Yahr, MDS-UPDRS, UDysRS, patient diary, PDQ-39, and EQ-5D-5L)
2. Eye movement (saccadic movement, eye blinks, eye blink speed, etc.)
3. Plasma levodopa concentration

Key secondary outcomes



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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Clinically established or probable Parkinson disease meeting the MDS clinical diagnosis criteria for Parkinson disease (2015)
2. Stage <= III on the Hoehn and Yahr scale in the ON state
3. Receiving treatment with L-DOPA for >= 6 months (26 weeks) and have been shown to be effective at the beginning of the administration
4. Advanced PD who will be hospitalized for medical evaluation, drug adjustment, and rehabilitation
5. Either hospitalized patient or outpatient
6. capable of giving a voluntary written informed consent after sufficient understanding of the research
7. Among those who use eyeglasses, those who can spend 6 hours corresponding to the evaluation time without using their own eyeglasses

Key exclusion criteria

1. Atypical Parkinsonism syndromes
2. Dementia or at high risk of it (Mini Mental State Examination (MMSE) score < = 20)
3. Contraindicated for concomitant medications (L-DOPA / carbidopa)
4. Hypersensitivity to concomitant medications (L-DOPA / carbidopa) and/or their ingredients
5. Co-existing psychiatric disease (e.g., depression, bipolar disorder or schizophrenia) and/or clinically significant complications (e.g., cerebrovascular accident, heart disease, chronic respiratory disease, uncontrolled hypertension and diabetes)
6. History of psychiatric disease (e.g., depression, bipolar disorder or schizophrenia) and/or device-aided therapies (i.e., GPi pallidotomy, thalamotomy, and deep brain stimulation)
7. Those who are judged by the principal investigator to be inappropriate as research subjects

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Noriko
Middle name
Last name Nishikawa

Organization

Juntendo University School of Medicine

Division name

Department of Neurology

Zip code

113-8431

Address

3-1-3, Hongou, Bunkyo-ku, Tokyo 113-8431 Japan

TEL

03-3813-3111

Email

n.nishikawa.ts@juntendo.ac.jp


Public contact

Name of contact person

1st name Noriko
Middle name
Last name Nishikawa

Organization

Juntendo University School of Medicine

Division name

Department of Neurology

Zip code

113-8431

Address

3-1-3, Hongou, Bunkyo-ku, Tokyo 113-8431 Japan

TEL

03-3813-3111

Homepage URL


Email

n.nishikawa.ts@juntendo.ac.jp


Sponsor or person

Institute

Department of Neurology
Juntendo University School of Medicine

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

Sumitomo Dainippon Pharma Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

the Ethical Review Committee of Juntendo University Faculty of Medicine

Address

3-1-3, Hongou, Bunkyo-ku, Tokyo 113-8431 Japan

Tel

03-3813-3111

Email

kenkyu5858@juntendo.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

順天堂大学医学部附属順天堂医院 (東京都)
Juntendo University Hospital (Tokyo, Japan)
大日本住友製薬株式会社 大阪研究所 (大阪府)
Sumitomo Dainippon Pharma, Osaka Research Center (Osaka, Japan)


Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 18 Day


Related information

URL releasing protocol

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=web&cd=&ved=0CAIQw7AJahcKEwigofnAjff_AhUAAAAA

Publication of results

Unpublished


Result

URL related to results and publications

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=web&cd=&ved=0CAIQw7AJahcKEwigofnAjff_AhUAAAAA

Number of participants that the trial has enrolled

20

Results

The MDS-UPDRS Part III score of PD motor symptoms, the ON/OFF score of the patient symptom diary, and the L-dopa blood concentration showed similar trends to the blink frequency. Furthermore, by extracting various parameters such as blink duration and confidence from the blink information and applying machine learning, we constructed a model to estimate clinical symptoms at the same point in time from 3 minutes of blink data. UPDRS Part III score in real time.

Results date posted

2023 Year 07 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Parkinson's disease patient with wearing-off phenomenon

Participant flow

Twenty cases were recruited, all of whom carried out the study.

Adverse events

none

Outcome measures

MDS-UPDRS part 3
Blink imformation

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2021 Year 02 Month 12 Day

Date of IRB

2021 Year 03 Month 18 Day

Anticipated trial start date

2021 Year 05 Month 17 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

The aim of present study is to investigate the correlation between eye movement, clinical evaluation scale and plasma levodopa concentration during administration of levodopa in Parkinson's disease patients.


Management information

Registered date

2021 Year 05 Month 18 Day

Last modified on

2023 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050531


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name