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
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
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
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
