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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044246
Receipt No. 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 2021/11/25

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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
Institute Department of Neurology
Juntendo University School of Medicine
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 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
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
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
2021 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.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


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