Trial Outcomes & Findings for Flexible-Dose Trial in Early Parkinson's Disease (PD) (NCT NCT04223193)
NCT ID: NCT04223193
Last Updated: 2025-11-21
Results Overview
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
Week 26
Results posted on
2025-11-21
Participant Flow
In this Phase 3, Double-Blind study, a total of 304 participants with Parkinson's Disease (PD) were randomized in a 1:1 ratio to either Placebo, or tavapadon 5 mg to 15 mg once daily (QD) for 27 Weeks.
Participant milestones
| Measure |
Placebo
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
151
|
|
Overall Study
COMPLETED
|
130
|
94
|
|
Overall Study
NOT COMPLETED
|
23
|
57
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
36
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Failure to Meet Continuation Criteria
|
1
|
0
|
|
Overall Study
Treatment with Prohibited Concomitant Medications
|
3
|
0
|
|
Overall Study
Non-Compliance with Study Drug
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Site Terminated by Sponsor
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Other
|
3
|
6
|
Baseline Characteristics
Flexible-Dose Trial in Early Parkinson's Disease (PD)
Baseline characteristics by cohort
| Measure |
Placebo
n=153 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=151 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 9.43 • n=68 Participants
|
63.1 years
STANDARD_DEVIATION 8.98 • n=76 Participants
|
62.9 years
STANDARD_DEVIATION 9.20 • n=48 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=68 Participants
|
67 Participants
n=76 Participants
|
135 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=68 Participants
|
84 Participants
n=76 Participants
|
169 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=68 Participants
|
5 Participants
n=76 Participants
|
16 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=68 Participants
|
141 Participants
n=76 Participants
|
278 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=68 Participants
|
5 Participants
n=76 Participants
|
10 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=68 Participants
|
17 Participants
n=76 Participants
|
32 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
2 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=68 Participants
|
134 Participants
n=76 Participants
|
268 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
|
MDS-UPDRS Score at Baseline (Parts II and III Combined)
|
30.0 units on a scale
STANDARD_DEVIATION 11.11 • n=68 Participants
|
31.1 units on a scale
STANDARD_DEVIATION 11.21 • n=76 Participants
|
30.5 units on a scale
STANDARD_DEVIATION 11.16 • n=48 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: mITT Population includes subjects who receive at least 1 dose of study drug and have both a baseline and at least 1 postbaseline MDS-UPDRS assessment, and had available data for analysis.
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.
Outcome measures
| Measure |
Placebo
n=133 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=99 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score
|
-1.2 score on a scale
Standard Error 0.89
|
-10.3 score on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Week 26Population: mITT Population includes subjects who receive at least 1 dose of study drug and have both a baseline and at least 1 postbaseline MDS-UPDRS assessment, and had available data for analysis.
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function.
Outcome measures
| Measure |
Placebo
n=134 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=99 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the MDS-UPDRS Part II Score
|
0.0 score on a scale
Standard Error 0.30
|
-1.5 score on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Week 26Population: mITT Population includes subjects who receive at least 1 dose of study drug and have both a baseline and at least 1 postbaseline PGIC assessment, and had available data for analysis.
The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=134 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=99 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Percentage of Responders With "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (PGIC)
|
25 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: mITT Population
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.
Outcome measures
| Measure |
Placebo
n=151 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=150 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 5
|
-2.1 score on a scale
Standard Error 0.58
|
-5.5 score on a scale
Standard Error 0.63
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 8
|
-2.4 score on a scale
Standard Error 0.64
|
-8.5 score on a scale
Standard Error 0.69
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 11
|
-2.3 score on a scale
Standard Error 0.71
|
-9.5 score on a scale
Standard Error 0.77
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 14
|
-2.2 score on a scale
Standard Error 0.76
|
-10.3 score on a scale
Standard Error 0.84
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 18
|
-2.2 score on a scale
Standard Error 0.85
|
-10.0 score on a scale
Standard Error 0.93
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 22
|
-1.3 score on a scale
Standard Error 0.82
|
-10.1 score on a scale
Standard Error 0.92
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 26
|
-1.2 score on a scale
Standard Error 0.89
|
-10.3 score on a scale
Standard Error 0.99
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 27
|
-1.2 score on a scale
Standard Error 0.89
|
-10.4 score on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: mITT Population
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 1, 2, and 3 combined is the sum of Part 1, Part 2, and Part 3 scores at each assessment time for each participant. The combined score assesses 44 items with score range: 0-236.
Outcome measures
| Measure |
Placebo
n=151 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=150 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 5
|
-2.7 score on a scale
Standard Error 0.67
|
-5.2 score on a scale
Standard Error 0.72
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 8
|
-3.2 score on a scale
Standard Error 0.73
|
-8.3 score on a scale
Standard Error 0.79
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 11
|
-3.2 score on a scale
Standard Error 0.82
|
-9.3 score on a scale
Standard Error 0.89
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 14
|
-3.0 score on a scale
Standard Error 0.88
|
-10.4 score on a scale
Standard Error 0.96
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 18
|
-2.9 score on a scale
Standard Error 0.96
|
-10.1 score on a scale
Standard Error 1.05
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 22
|
-1.8 score on a scale
Standard Error 0.96
|
-10.1 score on a scale
Standard Error 1.07
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 26
|
-1.6 score on a scale
Standard Error 1.03
|
-9.9 score on a scale
Standard Error 1.15
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 27
|
-1.8 score on a scale
Standard Error 1.03
|
-10.2 score on a scale
Standard Error 1.14
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: mITT Population
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function.
Outcome measures
| Measure |
Placebo
n=151 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=150 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 11
|
-0.8 score on a scale
Standard Error 0.25
|
0.2 score on a scale
Standard Error 0.27
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 22
|
-0.5 score on a scale
Standard Error 0.27
|
0.0 score on a scale
Standard Error 0.30
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 26
|
-0.4 score on a scale
Standard Error 0.29
|
0.3 score on a scale
Standard Error 0.32
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 5
|
-0.6 score on a scale
Standard Error 0.23
|
0.4 score on a scale
Standard Error 0.25
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 8
|
-0.8 score on a scale
Standard Error 0.25
|
0.2 score on a scale
Standard Error 0.27
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 14
|
-0.7 score on a scale
Standard Error 0.25
|
-0.1 score on a scale
Standard Error 0.27
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 18
|
-0.7 score on a scale
Standard Error 0.25
|
-0.2 score on a scale
Standard Error 0.27
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 27
|
-0.6 score on a scale
Standard Error 0.28
|
0.2 score on a scale
Standard Error 0.31
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 5
|
-0.6 score on a scale
Standard Error 0.22
|
-1.0 score on a scale
Standard Error 0.24
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 8
|
-0.4 score on a scale
Standard Error 0.23
|
-1.5 score on a scale
Standard Error 0.25
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 11
|
-0.2 score on a scale
Standard Error 0.26
|
-1.4 score on a scale
Standard Error 0.28
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 14
|
-0.4 score on a scale
Standard Error 0.26
|
-1.7 score on a scale
Standard Error 0.29
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 18
|
-0.3 score on a scale
Standard Error 0.27
|
-1.5 score on a scale
Standard Error 0.30
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 22
|
0.2 score on a scale
Standard Error 0.29
|
-1.4 score on a scale
Standard Error 0.32
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 26
|
0.0 score on a scale
Standard Error 0.30
|
-1.5 score on a scale
Standard Error 0.33
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 27
|
0.0 score on a scale
Standard Error 0.30
|
-1.3 score on a scale
Standard Error 0.34
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 5
|
-1.5 score on a scale
Standard Error 0.48
|
-4.5 score on a scale
Standard Error 0.52
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 8
|
-2.0 score on a scale
Standard Error 0.53
|
-7.0 score on a scale
Standard Error 0.58
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 11
|
-2.2 score on a scale
Standard Error 0.58
|
-8.1 score on a scale
Standard Error 0.64
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 14
|
-1.9 score on a scale
Standard Error 0.63
|
-8.6 score on a scale
Standard Error 0.69
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 18
|
-1.9 score on a scale
Standard Error 0.69
|
-8.4 score on a scale
Standard Error 0.77
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 22
|
-1.5 score on a scale
Standard Error 0.68
|
-8.7 score on a scale
Standard Error 0.76
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 26
|
-1.2 score on a scale
Standard Error 0.71
|
-8.9 score on a scale
Standard Error 0.80
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 27
|
-1.2 score on a scale
Standard Error 0.71
|
-9.0 score on a scale
Standard Error 0.80
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: mITT Population
The Global Impression - Severity of Illness (CGI-S) Score is a clinician's impression of a participant's severity of illness on a 7-point scale. Scores ranged from 1-7 on a scale of 1 (normal) to 7 (among the most extremely ill participants). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=151 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=150 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 14
|
0.0 score on a scale
Standard Error 0.05
|
-0.3 score on a scale
Standard Error 0.05
|
|
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 18
|
0.0 score on a scale
Standard Error 0.05
|
-0.3 score on a scale
Standard Error 0.06
|
|
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 22
|
0.0 score on a scale
Standard Error 0.05
|
-0.4 score on a scale
Standard Error 0.06
|
|
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 26
|
0.0 score on a scale
Standard Error 0.06
|
-0.4 score on a scale
Standard Error 0.06
|
|
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 27
|
0.0 score on a scale
Standard Error 0.05
|
-0.3 score on a scale
Standard Error 0.06
|
|
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 11
|
0.0 score on a scale
Standard Error 0.05
|
-0.3 score on a scale
Standard Error 0.06
|
|
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 5
|
0.0 score on a scale
Standard Error 0.04
|
-0.2 score on a scale
Standard Error 0.05
|
|
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 8
|
0.0 score on a scale
Standard Error 0.05
|
-0.2 score on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: mITT Population
The Clinical Global Impression - Improvement (CGI-I) Score is a clinician's impression of how much the participant's illness has improved or worsened relative to the baseline on a 7-point scale. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=151 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=150 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Clinical Global Impression - Improvement (CGI-I) Score
Week 5
|
3.6 units on a scale
Standard Error 0.06
|
3.3 units on a scale
Standard Error 0.07
|
|
Clinical Global Impression - Improvement (CGI-I) Score
Week 8
|
3.5 units on a scale
Standard Error 0.07
|
3.1 units on a scale
Standard Error 0.08
|
|
Clinical Global Impression - Improvement (CGI-I) Score
Week 14
|
3.6 units on a scale
Standard Error 0.08
|
2.9 units on a scale
Standard Error 0.09
|
|
Clinical Global Impression - Improvement (CGI-I) Score
Week 18
|
3.7 units on a scale
Standard Error 0.09
|
2.8 units on a scale
Standard Error 0.10
|
|
Clinical Global Impression - Improvement (CGI-I) Score
Week 22
|
3.6 units on a scale
Standard Error 0.09
|
2.8 units on a scale
Standard Error 0.10
|
|
Clinical Global Impression - Improvement (CGI-I) Score
Week 26
|
3.7 units on a scale
Standard Error 0.10
|
2.7 units on a scale
Standard Error 0.11
|
|
Clinical Global Impression - Improvement (CGI-I) Score
Week 27
|
3.7 units on a scale
Standard Error 0.09
|
2.8 units on a scale
Standard Error 0.11
|
|
Clinical Global Impression - Improvement (CGI-I) Score
Week 11
|
3.5 units on a scale
Standard Error 0.08
|
3.0 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: mITT Population
The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=151 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=150 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the PGIC Score
Week 5
|
3.5 score on a scale
Standard Error 0.08
|
3.3 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the PGIC Score
Week 8
|
3.6 score on a scale
Standard Error 0.09
|
3.1 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the PGIC Score
Week 11
|
3.6 score on a scale
Standard Error 0.09
|
3.1 score on a scale
Standard Error 0.10
|
|
Change From Baseline in the PGIC Score
Week 14
|
3.6 score on a scale
Standard Error 0.10
|
2.9 score on a scale
Standard Error 0.11
|
|
Change From Baseline in the PGIC Score
Week 18
|
3.7 score on a scale
Standard Error 0.10
|
2.9 score on a scale
Standard Error 0.12
|
|
Change From Baseline in the PGIC Score
Week 22
|
3.7 score on a scale
Standard Error 0.10
|
2.9 score on a scale
Standard Error 0.12
|
|
Change From Baseline in the PGIC Score
Week 26
|
3.8 score on a scale
Standard Error 0.11
|
2.8 score on a scale
Standard Error 0.12
|
|
Change From Baseline in the PGIC Score
Week 27
|
3.8 score on a scale
Standard Error 0.11
|
2.8 score on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Week 26Population: FAS population includes all randomized participants who received at least 1 dose of study drug, and had available data for analysis.
The ESS is an 8-question, participant questionnaire that is intended to measure daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in the following common situations: sitting and reading, sitting inactive in a public place as a passenger in a car for an hour or more without stopping for a break, lying down to rest when circumstances permit, sitting and talking to someone, sitting quietly after a meal without alcohol, and in a car while stopped for a few minutes in traffic or at a light. Each situation is rated on a 4-point (0-3) scale with scores ranging from 0 (would never nod off) to 3 (high chance of nodding off). Higher values represent a worse outcome. A negative change from baseline represents an improvement in daytime sleepiness. The total ESS score range was 0 - 24.
Outcome measures
| Measure |
Placebo
n=134 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=98 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the Epworth Sleepiness Scale (ESS)
|
-0.1 score on a scale
Standard Error 0.22
|
-0.1 score on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Week 26Population: FAS population includes all randomized participants who received at least 1 dose of study drug, and had available data for analysis.
QUIP-RS is a questionnaire for impulse-compulsive disorders in Parkinson's disease rating scale to assess impulse control disorders (ICD). The QUIP-RS has 4 primary questions that pertain to commonly reported thoughts, urges/ desires, and behaviors associated with ICDs, each of which is applied to 4 ICDs (compulsive gambling, buying, eating, sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). The QUIP-RS uses a 5-point Likert scale (score 0-4 \[0 means "never" and 4 means "very often"\] for each question) to gauge the frequency of behaviors. Scores for each ICD and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112. A higher score indicating greater severity of symptoms. A negative change from baseline represents an improvement in ICDs.
Outcome measures
| Measure |
Placebo
n=134 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=99 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)
|
-1.9 score on a scale
Standard Error 0.31
|
-2.0 score on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Week 27Population: FAS population
The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation (SI) categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=151 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants With Any Suicidal Behaviors
|
0 Participants
|
0 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants With Non-Suicidal Self-Injurious Behavior
|
0 Participants
|
0 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants With Any Suicidal Ideations
|
0 Participants
|
5 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants With Any Suicidal Behaviors or Ideations
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until 190 days following last dose of study drug.Population: FAS Population
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=151 Participants
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
84 Participants
|
115 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TESAE
|
2 Participants
|
7 Participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Tavapadon
Serious events: 7 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=153 participants at risk
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=151 participants at risk
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
HYPERCHROMIC ANAEMIA
|
0.65%
1/153 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.00%
0/151 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FALL
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
1.3%
2/151 • Number of events 2 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FEMORAL NECK FRACTURE
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.66%
1/151 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
HEAD INJURY
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.66%
1/151 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
JOINT INJURY
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.66%
1/151 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
NERVOUS SYSTEM DISORDERS
PRESYNCOPE
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.66%
1/151 • Number of events 2 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
NERVOUS SYSTEM DISORDERS
REVERSIBLE CEREBRAL VASOCONSTRICTION SYNDROME
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.66%
1/151 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
PSYCHIATRIC DISORDERS
DEPRESSION
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.66%
1/151 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
HYPERHIDROSIS
|
0.65%
1/153 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.00%
0/151 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
VASCULAR DISORDERS
HYPERTENSION
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.66%
1/151 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
Other adverse events
| Measure |
Placebo
n=153 participants at risk
Participants received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon
n=151 participants at risk
Participants received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
2.0%
3/153 • Number of events 3 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
4.0%
6/151 • Number of events 6 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
1.3%
2/153 • Number of events 2 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
2.6%
4/151 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
GASTROINTESTINAL DISORDERS
DRY MOUTH
|
0.65%
1/153 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
3.3%
5/151 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
GASTROINTESTINAL DISORDERS
DYSPEPSIA
|
1.3%
2/153 • Number of events 3 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
4.0%
6/151 • Number of events 6 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
GASTROINTESTINAL DISORDERS
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.3%
2/153 • Number of events 2 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
4.0%
6/151 • Number of events 7 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
3.3%
5/153 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
29.8%
45/151 • Number of events 54 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
GASTROINTESTINAL DISORDERS
SALIVARY HYPERSECRETION
|
1.3%
2/153 • Number of events 2 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
3.3%
5/151 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
7.9%
12/151 • Number of events 14 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
|
1.3%
2/153 • Number of events 2 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
5.3%
8/151 • Number of events 9 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
0.65%
1/153 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
7.9%
12/151 • Number of events 14 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
INFECTIONS AND INFESTATIONS
BRONCHITIS
|
2.6%
4/153 • Number of events 4 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.00%
0/151 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
INFECTIONS AND INFESTATIONS
COVID-19
|
5.2%
8/153 • Number of events 8 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
3.3%
5/151 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
INFECTIONS AND INFESTATIONS
UPPER RESPIRATORY TRACT INFECTION
|
4.6%
7/153 • Number of events 7 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
2.0%
3/151 • Number of events 3 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
2.6%
4/153 • Number of events 4 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
3.3%
5/151 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FALL
|
2.0%
3/153 • Number of events 4 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
5.3%
8/151 • Number of events 10 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
|
0.65%
1/153 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
2.6%
4/151 • Number of events 4 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
|
3.9%
6/153 • Number of events 6 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
4.6%
7/151 • Number of events 7 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
4.6%
7/153 • Number of events 8 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
2.6%
4/151 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN EXTREMITY
|
2.6%
4/153 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.00%
0/151 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
NERVOUS SYSTEM DISORDERS
DIZZINESS
|
3.3%
5/153 • Number of events 7 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
15.9%
24/151 • Number of events 28 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
NERVOUS SYSTEM DISORDERS
DYSGEUSIA
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
7.9%
12/151 • Number of events 12 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
NERVOUS SYSTEM DISORDERS
HEADACHE
|
5.2%
8/153 • Number of events 11 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
16.6%
25/151 • Number of events 37 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
NERVOUS SYSTEM DISORDERS
PARAESTHESIA
|
2.6%
4/153 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
2.6%
4/151 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
NERVOUS SYSTEM DISORDERS
PARKINSON'S DISEASE
|
2.6%
4/153 • Number of events 4 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
0.66%
1/151 • Number of events 1 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
NERVOUS SYSTEM DISORDERS
SOMNOLENCE
|
3.9%
6/153 • Number of events 7 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
3.3%
5/151 • Number of events 6 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
NERVOUS SYSTEM DISORDERS
TREMOR
|
8.5%
13/153 • Number of events 15 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
2.0%
3/151 • Number of events 3 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
PSYCHIATRIC DISORDERS
ABNORMAL DREAMS
|
0.65%
1/153 • Number of events 2 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
3.3%
5/151 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
PSYCHIATRIC DISORDERS
ANXIETY
|
1.3%
2/153 • Number of events 2 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
3.3%
5/151 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
PSYCHIATRIC DISORDERS
INSOMNIA
|
3.3%
5/153 • Number of events 5 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
4.0%
6/151 • Number of events 6 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
|
VASCULAR DISORDERS
HYPOTENSION
|
0.00%
0/153 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
4.0%
6/151 • Number of events 7 • All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER