Back to resultsA Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease Patients
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
WIN-1001X
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Subjects ≥30 years old at the time of informed consent
- Subjects diagnosed with Parkinson's disease satisfying the UKPDSBB (United Kingdom Parkinson's Disease Society Brain Bank) Clinical Diagnostic Criteria and showing decreased dopamine transporters in the dopamine transporter imaging (e.g.: ¹⁸F-FP-CIT PET, etc.)
- Modified Hoehn and Yahr stage ≤ 3.0
- K-MMSE (Korean Mini-Mental State Examination) score ≥20 at the screening visit (visit 1)
- Subjects who can understand and follow the instructions on this clinical study, and fully participate in the clinical study
- MDS UPDRS Part Ⅱ+Part Ⅲ score ≥18 at baseline (visit 2)
- Subjects who have voluntarily determined to participate in this study and signed the written informed consent form
Exclusion Criteria:
- Atypical or secondary parkinsonism or benign tremulous parkinsonism
- History of treatments with levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine, or NMDA receptor antagonists (However, subjects who have not been administered such drugs for at least 6 months in a row and have no history of treatment within 4 weeks prior to their written consent can be enrolled)
- In case the investigators determine the symptom control is difficult with placebo
- Hypersensitivity to herbal medicine
- Subjects with dementia whose K-MMSE score is ≤19, severe psychopathy requiring treatment or hallucination
- Any disorder that may affect the absorption, distribution, metabolism, and excretion of drugs
- History of surgical treatment for Parkinson's disease
- Subjects who have been administered another investigational product within 30 days prior to screening
- Female subjects who are pregnant or lactating, or who have child-bearing potential (i.e., (i) those who are not surgically non-infertile, or (ii) who are not using adequate contraceptive methods [including at least one of the barrier methods], or (iii) who are not sexually abstinent, or (iv) for whom at least 2 years have not elapsed since their last menstruation)
- History of chronic alcohol or drug abuse within last 6 months
- Subjects who are otherwise considered to be ineligible for this study on investigators' judgment
Sites / Locations
- Yeouido St.Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Test Group 1
Test Group 2
Test Group 3
Placebo group
Arm Description
The randomized patients are administered 3 tablets of the investigational product (400mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
The randomized patients are administered 3 tablets of the investigational product (800mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
The randomized patients are administered 3 tablets of the investigational product (1200mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
The randomized patients are administered 3 tablets of the placebo drug twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Outcomes
Primary Outcome Measures
Change in MDS UPDRS Part Ⅲ
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Secondary Outcome Measures
Change in the MDS UPDRS Part Ⅲ
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Change in the MDS UPDRS Part Ⅰ
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I. MDS-UPDRS Part I measures non-motor experiences of daily living. Part I consists of 13 questions/evaluations, and each question is anchored with five response scale from 0(normal) to 4(severe).
Change in the MDS UPDRS Part Ⅱ
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. MDS-UPDRS Part II measures motor experiences of daily living. Part II consists of 13 questions/evaluations, and each question is anchored with five response scale from 0(normal) to 4(severe).
Change in the MDS UPDRS Part Ⅰ+Part Ⅱ+Part Ⅲ
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I+II+III. MDS-UPDRS Part I measures non-motor experiences of daily living, Part II measures motor experiences of daily living and Part III measures motor examination. Part I and II each consists of 13 questions/evaluations and Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Change in the Modified Hoehn and Yahr scale
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress. The Hoehn and Yahr scale includes stages 1 through 5, with addition of stages 1.5 and 2.5 to help describe the intermediate course of the disease. The higher the score, the more severe the symptoms of Parkinson's disease progress.
Changes in each and total scores of K-NMSS
Korean version of Novel Non-Motor Symptoms Scale for Parkinson's Disease is 30-item scale containing nine dimensions: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems, attention/memory, gastrointestinal, urinary, sexual function and miscellany. Each symptoms are scored with severity (0=none, 1=mild, 2=moderate) and frequency (1=rarely, 2=often, 3=frequent, 4=very frequent). The final scores are calculated as severity score x frequency score. The higher the score, the severe the symptoms.
Change in the K-MoCA
The Montreal Cognitive Assessment (MoCA) is a screening assessment for detecting cognitive impairment. It is a 30-point test consisting of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points and a score of 26 or above is considered normal.
Changes in the summary index and total scores of the K-PDQ-39
The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assessment is carried out across the 8 quality of life dimensions; activities of daily living, attention & working memory, cognition, communication, depression, functional mobility, quality of life, social relationships and social support. All items are scored from 0 (never) to 4 (always). Dimension score is then calculated by sum of scores of each item in the dimension divided by the maximum possible socre of all the items in the dimension, multiplied by 100. Lower dimension score reflects better quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04220762
Brief Title
A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease Patients
Official Title
A Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medi Help Line
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to determine the optimal dose of WIN-1001X for its therapeutic confirmatory study by comparing and evaluating the efficacy and safety of each dose group by conducting a therapeutic exploratory study on three dose groups of WIN-1001X 400 mg, 800 mg, and 1200 mg, and placebo group in patients with early Parkinson's disease.
Detailed Description
The primary objective of this study is to evaluate the difference in the change of MDS UPDRS Part Ⅲ between WIN-1001X 400 mg, 800 mg, and 1200 mg as the test drugs compared to placebo as the control drug after administering them for 12 weeks.
The secondary objectives of this study are to evaluate the therapeutic efficacy and safety of the 3 dose groups of WIN-1001X compared to placebo group by assessing the changes in MDS UPDRS Part Ⅲ after administering the investigational products for 4 and 8 weeks, the changes in MDS UPDRS Part Ⅰ, Part Ⅱ, Part Ⅰ+Part Ⅱ+Part Ⅲ, and Modified Hoehn and Yahr scale after administering for 4, 8, and 12 weeks, the changes in K-NMSS (Non-Motor Symptoms Scale), K-MoCA (Korean-Montreal Cognitive Assessment), K-PDQ-39 (Parkinson's Disease Questionnaire) score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Group 1
Arm Type
Experimental
Arm Description
The randomized patients are administered 3 tablets of the investigational product (400mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Arm Title
Test Group 2
Arm Type
Experimental
Arm Description
The randomized patients are administered 3 tablets of the investigational product (800mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Arm Title
Test Group 3
Arm Type
Experimental
Arm Description
The randomized patients are administered 3 tablets of the investigational product (1200mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The randomized patients are administered 3 tablets of the placebo drug twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Intervention Type
Drug
Intervention Name(s)
WIN-1001X
Intervention Description
This study has been designed as a randomized, double-blind, and placebo-controlled study.
Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
This study has been designed as a randomized, double-blind, and placebo-controlled study.
Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Primary Outcome Measure Information:
Title
Change in MDS UPDRS Part Ⅲ
Description
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Time Frame
From baseline (0d) after administration of the investigational product for 12 weeks
Secondary Outcome Measure Information:
Title
Change in the MDS UPDRS Part Ⅲ
Description
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Time Frame
After administration of the investigational product for 4 and 8 weeks
Title
Change in the MDS UPDRS Part Ⅰ
Description
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I. MDS-UPDRS Part I measures non-motor experiences of daily living. Part I consists of 13 questions/evaluations, and each question is anchored with five response scale from 0(normal) to 4(severe).
Time Frame
After administration of the investigational product for 4, 8, and 12 weeks
Title
Change in the MDS UPDRS Part Ⅱ
Description
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. MDS-UPDRS Part II measures motor experiences of daily living. Part II consists of 13 questions/evaluations, and each question is anchored with five response scale from 0(normal) to 4(severe).
Time Frame
After administration of the investigational product for 4, 8, and 12 weeks
Title
Change in the MDS UPDRS Part Ⅰ+Part Ⅱ+Part Ⅲ
Description
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I+II+III. MDS-UPDRS Part I measures non-motor experiences of daily living, Part II measures motor experiences of daily living and Part III measures motor examination. Part I and II each consists of 13 questions/evaluations and Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Time Frame
After administration of the investigational product for 4, 8, and 12 weeks
Title
Change in the Modified Hoehn and Yahr scale
Description
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress. The Hoehn and Yahr scale includes stages 1 through 5, with addition of stages 1.5 and 2.5 to help describe the intermediate course of the disease. The higher the score, the more severe the symptoms of Parkinson's disease progress.
Time Frame
After administration of the investigational product for 4, 8, and 12 weeks
Title
Changes in each and total scores of K-NMSS
Description
Korean version of Novel Non-Motor Symptoms Scale for Parkinson's Disease is 30-item scale containing nine dimensions: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems, attention/memory, gastrointestinal, urinary, sexual function and miscellany. Each symptoms are scored with severity (0=none, 1=mild, 2=moderate) and frequency (1=rarely, 2=often, 3=frequent, 4=very frequent). The final scores are calculated as severity score x frequency score. The higher the score, the severe the symptoms.
Time Frame
After administration of the investigational product for 4 and 12 weeks
Title
Change in the K-MoCA
Description
The Montreal Cognitive Assessment (MoCA) is a screening assessment for detecting cognitive impairment. It is a 30-point test consisting of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points and a score of 26 or above is considered normal.
Time Frame
After administration of the investigational product for 4 and 12 weeks
Title
Changes in the summary index and total scores of the K-PDQ-39
Description
The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assessment is carried out across the 8 quality of life dimensions; activities of daily living, attention & working memory, cognition, communication, depression, functional mobility, quality of life, social relationships and social support. All items are scored from 0 (never) to 4 (always). Dimension score is then calculated by sum of scores of each item in the dimension divided by the maximum possible socre of all the items in the dimension, multiplied by 100. Lower dimension score reflects better quality of life.
Time Frame
After administration of the investigational product for 4 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects ≥30 years old at the time of informed consent
Subjects diagnosed with Parkinson's disease satisfying the UKPDSBB (United Kingdom Parkinson's Disease Society Brain Bank) Clinical Diagnostic Criteria and showing decreased dopamine transporters in the dopamine transporter imaging (e.g.: ¹⁸F-FP-CIT PET, etc.)
Modified Hoehn and Yahr stage ≤ 3.0
K-MMSE (Korean Mini-Mental State Examination) score ≥20 at the screening visit (visit 1)
Subjects who can understand and follow the instructions on this clinical study, and fully participate in the clinical study
MDS UPDRS Part Ⅱ+Part Ⅲ score ≥18 at baseline (visit 2)
Subjects who have voluntarily determined to participate in this study and signed the written informed consent form
Exclusion Criteria:
Atypical or secondary parkinsonism or benign tremulous parkinsonism
History of treatments with levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine, or NMDA receptor antagonists (However, subjects who have not been administered such drugs for at least 6 months in a row and have no history of treatment within 4 weeks prior to their written consent can be enrolled)
In case the investigators determine the symptom control is difficult with placebo
Hypersensitivity to herbal medicine
Subjects with dementia whose K-MMSE score is ≤19, severe psychopathy requiring treatment or hallucination
Any disorder that may affect the absorption, distribution, metabolism, and excretion of drugs
History of surgical treatment for Parkinson's disease
Subjects who have been administered another investigational product within 30 days prior to screening
Female subjects who are pregnant or lactating, or who have child-bearing potential (i.e., (i) those who are not surgically non-infertile, or (ii) who are not using adequate contraceptive methods [including at least one of the barrier methods], or (iii) who are not sexually abstinent, or (iv) for whom at least 2 years have not elapsed since their last menstruation)
History of chronic alcohol or drug abuse within last 6 months
Subjects who are otherwise considered to be ineligible for this study on investigators' judgment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joong-Seok Kim
Phone
+82-1588-1511
Email
neuronet@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ok Nam Park
Organizational Affiliation
Medihelpline Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Yeouido St.Mary's Hospital
City
Yeongdeungpo-dong
State/Province
Seoul
ZIP/Postal Code
04537
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon-Sang Oh
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease Patients
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