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This is a phase IIa, first in human, randomized, double-blind, multicenter study to evaluate the safety, tolerability and efficacy of DA-9805 at 45mg, 90mg versus placebo in subjects diagnosed with early Parkinson's disease.
Parkinson's disease (PD) is recognized as one of the most common neurologic disorders, affecting approximately 1% of individuals older than 60 years. There are 2 major neuropathologic findings: the loss of pigmented dopaminergic neurons in the substantia nigra pars compacta (SNpc) and the presence of Lewy bodies.
Parkinson's disease affects an estimated 1.5 million persons in the United States, with over ten million affected worldwide, and these estimates are expected to increase substantially in the next few decades. Despite the increasing prevalence, the approved agents for the early management of Parkinson's disease have changed little in the past decade; however, there have been advances in drug delivery, dosing, and the use of combination therapy in an attempt to reduce adverse events. The most important, unmet medical need in targeting Parkinson's disease is developing agents with neuroprotective potential. So far, no drug has been shown to reduce or slow down the progression of PD.
DA-9805 is a botanical drug product composed of three main raw herbal materials. It is expected that DA-9805 will help treat PD by prevention of dopaminergic neurodegeneration via recovery of mitochondrial dysfunction, anti-inflammatory effect and relief from Endoplasmic reticulum (ER) stress and oxidative stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo, tid |
|
| DA-9805 low | Experimental | DA-9805 45mg |
|
| DA-9805 high | Experimental | DA-9805 90mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-9805 45mg | Drug | DA-9805 15mg tid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor MDS-UPDRS Score From Baseline at Week 12 | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part II, Part III and Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total MDS- UPDRS Score | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part I, Part II, Part III and Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) |
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Inclusion Criteria:
Male or female subjects who are between 30 and 79 years old inclusive with a clinical diagnosis of Parkinson's disease as per UK Brain Bank Criteria for two (2) years or less at screening.
Hoehn and Yahr I or II at screening.
Subjects who are newly diagnosed & currently not on any Parkinson's disease medication (or) subjects who are on stable doses for at least 4 weeks prior to screening on Amantadine or anticholinergics for treatment of Parkinson's disease
*Note: Subjects that had anti-parkinsonian medication (including levodopa, dopamine agonists, entacapone and monoamine oxidase-B inhibitors) discontinued at least 60 days prior to screening, e.g., for intolerance, may be considered eligible if all other eligibility requirements are met.
Women of child-bearing potential should use reliable contraception. Acceptable methods of contraception include: surgical sterilization (e.g. bilateral tubal ligation), hormonal contraception (implantable, patch, and oral), and double-barrier methods (condom, diaphragm and spermicide are each considered a barrier). Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:
(1)Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/m, OR; (2)6 weeks post surgical bilateral oophorectomy with or without hysterectomy
If a male and heterosexually active with a female of childbearing potential, the subject must agree to use a double barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study.
Without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) the screening levels should be ≤ 2 times upper limit normal
Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sotirios A Parashos, MD, PhD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Institute | Bloomington | Minnesota | 55425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo, tid Placebo: Placebo, tid |
| FG001 | DA-9805 Low | DA-9805 45mg DA-9805 45mg: DA-9805 15mg tid |
| FG002 | DA-9805 High | DA-9805 90mg DA-9805 90mg: DA-9805 30mg tid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo, tid Placebo: Placebo, tid |
| BG001 | DA-9805 Low | DA-9805 45mg DA-9805 45mg: DA-9805 15mg tid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Motor MDS-UPDRS Score From Baseline at Week 12 | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part II, Part III and Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | ITT | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo, tid Placebo: Placebo, tid | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tremor | Nervous system disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaofei Du | Dong-A ST | 82-2-92-8457 | duxiaofeicat@donga.co.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2017 | Mar 17, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2018 | Mar 17, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000723230 | DA-9805 |
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| DA-9805 90mg | Drug | DA-9805 30mg tid |
|
|
| Placebo | Other | Placebo, tid |
|
| 12 weeks |
| Change in MDS-UPDRS Subscale scores_Part I | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part I at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | 12 weeks |
| Change in S&E Total Score | Change in Schwab and England (S&E) Scale total score from baseline at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) The Schwab & England Activities of Daily Living (ADL) scale reflects the speed, ease, and independence with which an individual performs daily activities, or personal chores, such as eating, toileting, and dressing. This scale uses a rating scale from 0% to 100%, with 100% representing complete independence in performing daily activities and 0% representing a vegetative, bedridden state. | 12 weeks |
| Change in PDQ-39 Score- Summary Index | Change in Parkinson's Disease Questionnaire (PDQ-39) total score from baseline at week 12.(Change from baseline = Post Baseline Measurement - Baseline Measurement) The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [6 items], emotional wellbeing [6 items], stigma [4 items], cognition [4 items], social support [3 items], communication [3 items] and bodily discomfort [3 items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale. The PDQ-39 Summary Index (PDQ-SI) is the sum of all answers divided by the highest score possible (i.e., number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0 - 100 scale where lower scores indicate a better perceived health status and higher scores are ass | 12 weeks |
| Change in H&Y Total Score at Week 12 | Change in Hoehn and Yahr (H&Y) scale total score from baseline at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) H&Y describes five stages to PD progression (Score 1~5). A lower score represent a lower amount of symptoms. | 12 weeks |
| Change in MDS-UPDRS Subscale scores_Part II | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part II at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | 12 weeks |
| Change in MDS-UPDRS Subscale scores_Part III | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | 12 weeks |
| Change in MDS-UPDRS Subscale scores_Part IV | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | 12 weeks |
| Change in Clinical Global Impression-Severity (CGI-S) | The Global Impression-Severity (CGI) measures global severity of illness at a given point in time, and the improvement from baseline at visits following the initial baseline visit. (Change from baseline = Post Baseline Measurement - Baseline Measurement) At the screening and baseline visit, the investigator assessed the severity on a seven-point scale. At subsequent visits, the investigator was to assess the subject's severity (CGI-S) and improvement (CGI-I) relative to baseline. Severity of Illness (CGI-S) Rating should account for severity of the patient's illness. 0 = Not assessed
| 12 weeks |
| Scores of Clinical Global Impression-Improvement (CGI-I) | The Global Impression-Severity (CGI) measures global severity of illness at a given point in time, and the improvement from baseline at visits following the initial baseline visit. At the screening and baseline visit, the investigator assessed the severity on a seven-point scale. At subsequent visits, the investigator was to assess the subject's severity (CGI-S) and improvement (CGI-I) relative to baseline. Global Improvement (CGI-I): Compared to the patient's condition at the baseline of this study, how much has the patient's illness improved or worsened? 0 = Not assessed
| 12 weeks |
| BG002 |
| DA-9805 High |
DA-9805 90mg DA-9805 90mg: DA-9805 30mg tid |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG000 |
| Placebo |
placebo, tid Placebo: Placebo, tid |
| OG001 | DA-9805 Low | DA-9805 45mg DA-9805 45mg: DA-9805 15mg tid |
| OG002 | DA-9805 High | DA-9805 90mg DA-9805 90mg: DA-9805 30mg tid |
|
|
|
| Secondary | Change in Total MDS- UPDRS Score | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part I, Part II, Part III and Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | ITT Population | Posted | Mean | Standard Deviation | score | 12 weeks |
|
|
|
|
| Secondary | Change in MDS-UPDRS Subscale scores_Part I | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part I at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | ITT population | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in S&E Total Score | Change in Schwab and England (S&E) Scale total score from baseline at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) The Schwab & England Activities of Daily Living (ADL) scale reflects the speed, ease, and independence with which an individual performs daily activities, or personal chores, such as eating, toileting, and dressing. This scale uses a rating scale from 0% to 100%, with 100% representing complete independence in performing daily activities and 0% representing a vegetative, bedridden state. | ITT population | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in PDQ-39 Score- Summary Index | Change in Parkinson's Disease Questionnaire (PDQ-39) total score from baseline at week 12.(Change from baseline = Post Baseline Measurement - Baseline Measurement) The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [6 items], emotional wellbeing [6 items], stigma [4 items], cognition [4 items], social support [3 items], communication [3 items] and bodily discomfort [3 items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale. The PDQ-39 Summary Index (PDQ-SI) is the sum of all answers divided by the highest score possible (i.e., number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0 - 100 scale where lower scores indicate a better perceived health status and higher scores are ass | ITT | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in H&Y Total Score at Week 12 | Change in Hoehn and Yahr (H&Y) scale total score from baseline at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) H&Y describes five stages to PD progression (Score 1~5). A lower score represent a lower amount of symptoms. | ITT | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in MDS-UPDRS Subscale scores_Part II | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part II at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | ITT population | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in MDS-UPDRS Subscale scores_Part III | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | ITT population | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in MDS-UPDRS Subscale scores_Part IV | Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0~26) | ITT population | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in Clinical Global Impression-Severity (CGI-S) | The Global Impression-Severity (CGI) measures global severity of illness at a given point in time, and the improvement from baseline at visits following the initial baseline visit. (Change from baseline = Post Baseline Measurement - Baseline Measurement) At the screening and baseline visit, the investigator assessed the severity on a seven-point scale. At subsequent visits, the investigator was to assess the subject's severity (CGI-S) and improvement (CGI-I) relative to baseline. Severity of Illness (CGI-S) Rating should account for severity of the patient's illness. 0 = Not assessed
| ITT population | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Scores of Clinical Global Impression-Improvement (CGI-I) | The Global Impression-Severity (CGI) measures global severity of illness at a given point in time, and the improvement from baseline at visits following the initial baseline visit. At the screening and baseline visit, the investigator assessed the severity on a seven-point scale. At subsequent visits, the investigator was to assess the subject's severity (CGI-S) and improvement (CGI-I) relative to baseline. Global Improvement (CGI-I): Compared to the patient's condition at the baseline of this study, how much has the patient's illness improved or worsened? 0 = Not assessed
| ITT population | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 20 |
| 0 |
| 20 |
| 11 |
| 20 |
| EG001 | DA-9805 Low | DA-9805 45mg DA-9805 45mg: DA-9805 15mg tid | 0 | 21 | 2 | 21 | 8 | 21 |
| EG002 | DA-9805 High | DA-9805 90mg DA-9805 90mg: DA-9805 30mg tid | 0 | 19 | 0 | 19 | 11 | 19 |
| STRESS CARDIOMYOPATHY | Cardiac disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Medial tibial stress syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Musculoskeletal pain | Metabolism and nutrition disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Change from baseline is based on subjects with paired values.
| ANCOVA |
| 0.2520 |
p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05. |
| Superiority |
Change from baseline is based on subjects with paired values.
| ANCOVA |
| 0.6146 |
p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score. All statistical tests for efficacy are two-sided tests, with α=0.05. |
| Superiority |
Change from baseline is based on subjects with paired values.
| ANCOVA |
| 0.1309 |
p-value is from ANCOVA model adjusted for baseline S&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05. |
| Superiority |
Change from baseline is based on subjects with paired values.
| ANCOVA |
| 0.9399 |
p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05. |
| Superiority |
Change from baseline is based on subjects with paired values.
| ANCOVA |
| 0.8880 |
p-value is from ANCOVA model adjusted for baseline H&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05. |
| Superiority |
Change from baseline is based on subjects with paired values.
| ANCOVA |
| 0.1517 |
p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score. All statistical tests for efficacy are two-sided tests, with α=0.05. |
| Superiority |
Change from baseline is based on subjects with paired values.
| ANCOVA |
| 0.6094 |
p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score. All statistical tests for efficacy are two-sided tests, with α=0.05. |
| Superiority |
Change from baseline is based on subjects with paired values.
| ANCOVA |
| 0.2260 |
p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score All statistical tests for efficacy are two-sided tests, with α=0.05. |
| Superiority |
Change from baseline is based on subjects with paired values.
| ANCOVA |
| 0.3416 |
p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05. |
| Superiority |
| 0.2643 |
P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05. |
| Superiority |