NCT03189563

Safety and Efficacy of DA-9805 for Parkinson's Disease

Completed Phase 2 Results posted Last updated 24 May 2022

What this trial tests

Phase 2 trial testing DA-9805 45mg in Parkinson's Disease in 61 participants. Completed in 10 April 2019.

Timeline

6 February 2018

Primary endpoint
10 April 2019

10 April 2019

Quick facts

Lead sponsor	Dong-A ST Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	61
Start date	6 February 2018
Primary completion	10 April 2019
Estimated completion	10 April 2019
Sites	1 location across United States

Drugs / interventions tested

• DA-9805 45mg — full drug profile →
• DA-9805 90mg — full drug profile →
• Placebo

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

Dong-A ST Co., Ltd. — full company profile →

Who can join

Adults 30 to 79, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Motor MDS-UPDRS Score From Baseline at Week 12 Primary · 12 weeks

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 livin

Group	Value	95% CI
Placebo	1.4	± 5.56
DA-9805 Low	-0.9	± 7.03
DA-9805 High	-1.2	± 8.41

Change in Total MDS- UPDRS Score Secondary · 12 weeks

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 dai

Group	Value	95% CI
Placebo	1.6	± 7.15
DA-9805 Low	-2.4	± 7.91
DA-9805 High	-1.7	± 9.16

Change in MDS-UPDRS Subscale scores_Part I Secondary · 12 weeks

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 rang

Group	Value	95% CI
Placebo	0.1	± 3.3
DA-9805 Low	-1.3	± 2.82
DA-9805 High	-0.5	± 3.04

Change in S&E Total Score Secondary · 12 weeks

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.

Group	Value	95% CI
Placebo	2.0	± 8.34
DA-9805 Low	1.0	± 7.00
DA-9805 High	0.5	± 5.24

Change in PDQ-39 Score- Summary Index Secondary · 12 weeks

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 follow

Group	Value	95% CI
Placebo	-1.3	± 4.95
DA-9805 Low	-1.7	± 4.58
DA-9805 High	-1.5	± 4.57

Change in H&Y Total Score at Week 12 Secondary · 12 weeks

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.

Group	Value	95% CI
Placebo	0.1	± 0.39
DA-9805 Low	0.0	± 0.59
DA-9805 High	0.1	± 0.46

Change in MDS-UPDRS Subscale scores_Part II Secondary · 12 weeks

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 ran

Group	Value	95% CI
Placebo	0.8	± 3.05
DA-9805 Low	1.3	± 2.26
DA-9805 High	-0.6	± 3.67

Change in MDS-UPDRS Subscale scores_Part III Secondary · 12 weeks

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 ra

Group	Value	95% CI
Placebo	0.7	± 5.0
DA-9805 Low	-1.7	± 6.21
DA-9805 High	-0.6	± 6.02

Change in MDS-UPDRS Subscale scores_Part IV Secondary · 12 weeks

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 ran

Group	Value	95% CI
Placebo	0.3	± 1.38
DA-9805 Low	-0.1	± 0.45
DA-9805 High	0.0	± 0.00

Change in Clinical Global Impression-Severity (CGI-S) Secondary · 12 weeks

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 1. = No

Group	Value	95% CI
Placebo	0.1	± 0.60
DA-9805 Low	0.0	± 0.67
DA-9805 High	0.1	± 0.71

Scores of Clinical Global Impression-Improvement (CGI-I) Secondary · 12 weeks

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 1. = Very much i

Group	Value	95% CI
Placebo	3.6	± 0.69
DA-9805 Low	3.8	± 0.54
DA-9805 High	3.9	± 1.12

Adverse events — posted to ClinicalTrials.gov

Time frame: 16 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/20 (0%)

Deaths: 0/20

DA-9805 Low

Serious: 2/21 (10%)

Deaths: 0/21

DA-9805 High

Serious: 0/19 (0%)

Deaths: 0/19

Serious adverse events (2 terms)

Reaction	System	Placebo	DA-9805 Low	DA-9805 High
Cholecystitis	Hepatobiliary disorders	—	—	—
STRESS CARDIOMYOPATHY	Cardiac disorders	—	—	—

Other adverse events (63 terms — click to expand)

Reaction	System	Placebo	DA-9805 Low	DA-9805 High
tremor	Nervous system disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Musculoskeletal pain	Metabolism and nutrition disorders	—	—	—
Pollakiuria	Renal and urinary disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Somnolence	Nervous system disorders	—	—	—
Syncope	Nervous system disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Atrioventricular block second degree	Cardiac disorders	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—
Chest discomfort	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Eye infection	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Sinusitis	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Viral infection	Infections and infestations	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—
Eye contusion	Injury, poisoning and procedural complications	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Foreign body in eye	Injury, poisoning and procedural complications	—	—	—
Muscle strain	Injury, poisoning and procedural complications	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Bilirubin conjugated increased	Investigations	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—
Blood bilirubin increased	Investigations	—	—	—
Blood creatinine increased	Investigations	—	—	—
Blood potassium increased	Investigations	—	—	—
Blood triglycerides increased	Investigations	—	—	—
Oxygen saturation decreased	Investigations	—	—	—

Most-reported serious reactions: Cholecystitis, STRESS CARDIOMYOPATHY.

Data from ClinicalTrials.gov NCT03189563 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Signaling pathways in Parkinson's disease: molecular mechanisms and therapeutic interventions.
   Dong-Chen X, Yong C, Yang X, Chen-Yu S, et al · · 2023 · cited 258× · PMID 36810524 · DOI 10.1038/s41392-023-01353-3
2. Inhibition of Protein Aggregation and Endoplasmic Reticulum Stress as a Targeted Therapy for α-Synucleinopathy.
   Siwecka N, Saramowicz K, Galita G, Rozpędek-Kamińska W, et al · · 2023 · cited 19× · PMID 37631265 · DOI 10.3390/pharmaceutics15082051
3. Neuroprotective Activity of Oligomeric Stilbenes from Alpha Grape Stems in In Vitro Models of Parkinson's Disease.
   Pislyagin EA, Tarbeeva DV, Yurchenko EA, Menchinskaya ES, et al · · 2025 · cited 4× · PMID 40141054 · DOI 10.3390/ijms26062411