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    Clinical Trial Results:
    A Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible-Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson’s Disease (TEMPO 2 Trial)

    Summary
    EudraCT number
    		 2019-002950-22
    Trial protocol
    		 FR   HU   IT  
    Global end of trial date
    01 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CVL-751-PD-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04223193
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Oct 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 47
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 42
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Serbia: 8
    Country: Number of subjects enrolled
    Thailand: 18
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    Ukraine: 25
    Country: Number of subjects enrolled
    United States: 86
    Worldwide total number of subjects
    304
    EEA total number of subjects
    148
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    159
    From 65 to 84 years
    145
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In this Phase 3, Double-Blind study, a total of 304 subjects 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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Treatment assignments were blinded to the investigators and other trial site personnel, the subjects, and all sponsor personnel who are involved in the conduct of the trial (including trial monitoring, data management, and data analysis). Access to the treatment codes will be restricted to personnel who are responsible for generating and maintaining the randomization code, packaging the IMPs, operating the IVRS/IWRS, analyzing the PK blood samples, or reporting serious adverse events (SAEs)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects will receive placebo matching to tavapadon tablet QD orally for 27 weeks.

    Arm title
    		 Tavapadon
    Arm description
    		 Subjects received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tavapadon
    Investigational medicinal product code
    Other name
    PF-06649751, CVL-751
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received tavapadon 5 mg QD to 15 mg QD tablet once daily orally for 27 weeks.

    Number of subjects in period 1
    		Placebo Tavapadon
    Started
    153
    151
    Completed
    130
    94
    Not completed
    23
    57
         Treatment with Prohibited Concomitant Medications
    3
    -
         Consent withdrawn by subject
    5
    6
         Non- Compliance with Study Drug
    -
    1
         Physician decision
    -
    1
         Failure to Meet Continuation Criteria
    1
    -
         Adverse event, non-fatal
    6
    36
         Other
    3
    6
         Protocol Violation
    1
    1
         Site Terminated by Sponsor
    1
    3
         Lost to follow-up
    1
    1
         Lack of efficacy
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.

    Reporting group title
    Tavapadon
    Reporting group description
    		 Subjects received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.

    Reporting group values
    		 Placebo Tavapadon Total
    Number of subjects
    		 153 151 304
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.6 ( 9.43 ) 63.1 ( 8.98 ) -
    Gender categorical
    Units: Subjects
        Female
    		 68 67 135
        Male
    		 85 84 169
    Ethnicity (NIH/ OMB)
    Units: Subjects
        Hispanic or Latino
    		 11 5 16
        Not Hispanic or Latino
    		 137 141 278
        Unknown or Not Reported
    		 5 5 10
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 15 17 32
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 2 0 2
        White
    		 134 134 268
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 0 1
    MDS-UPDRS Score at Baseline (Parts II and III Combined)
    The MDS-UPDRS rating tool was used to follow longitudinal course of Parkinson's Disease and consisted of 4 parts.Part 1:Non-motor aspects of experiences of daily living[13 items,Score range(SR):0-52];Part 2:Motor aspects of experiences of daily living(13 items,SR:0-52);Part 3:Motor examination(18 items,SR:0-132);Part 4:Motor complications(6 items,SR:0-24.Not collected).Each item has 0-4 rating on scale from 0(normal)-4(severe).Higher values represent a worse outcome.Parts 2 and 3 combined is the sum of Part 2 and Part 3 scores at each assessment time for each participant(31 items,SR:0-184).
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 30.0 ( 11.11 ) 31.1 ( 11.21 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching to Tavapadon tablet once daily (QD) orally for 27 weeks.

    Reporting group title
    Tavapadon
    Reporting group description
    		 Subjects received Tavapadon 5 mg to 15 mg tablet QD orally for 27 weeks.

    Primary: Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score

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    End point title
    		 Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score
    End point description
    The 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.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.
    End point type
    Primary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    133
    99
    Units: score on a scale
        least squares mean (standard error)
    -1.2 ( 0.89 )
    -10.3 ( 0.99 )
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.7
         upper limit
    		 -6.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.31
    Notes
    [1] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.

    Secondary: Change From Baseline in the MDS-UPDRS Part II Score

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    End point title
    		 Change From Baseline in the MDS-UPDRS Part II Score
    End point description
    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. Analysis Population Description: mITT Population
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    134
    99
    Units: score on a scale
        least squares mean (standard error)
    0.0 ( 0.30 )
    -1.5 ( 0.33 )
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007 [2]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 -0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.44
    Notes
    [2] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.

    Secondary: Percentage of Responders With "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (PGIC)

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    End point title
    		 Percentage of Responders With "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (PGIC)
    End point description
    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. Analysis Population Description: mITT Population
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    134
    99
    Units: participants
    25
    46
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Tavapadon v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.942
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.209
         upper limit
    		 7.037

    Secondary: Change From Baseline in the MDS-UPDRS Parts II and III Combined Score

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    End point title
    		 Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
    End point description
    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. Analysis Population Description: mITT Population
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    151
    150
    Units: score on a scale
    least squares mean (standard error)
        Week 5 (n = 148, 127)
    -2.1 ( 0.58 )
    -5.5 ( 0.63 )
        Week 8 (n = 145, 119)
    -2.4 ( 0.64 )
    -8.5 ( 0.69 )
        Week 11 (n = 141, 111)
    -2.3 ( 0.71 )
    -9.5 ( 0.77 )
        Week 14 (n = 140, 110)
    -2.2 ( 0.76 )
    -10.3 ( 0.84 )
        Week 18 (n = 138, 107)
    -2.2 ( 0.85 )
    -10.0 ( 0.93 )
        Week 22 (n = 137, 99)
    -1.3 ( 0.82 )
    -10.1 ( 0.92 )
        Week 26 (n = 133, 99)
    -1.2 ( 0.89 )
    -10.3 ( 0.99 )
        Week 27 (n = 134, 100)
    -1.2 ( 0.89 )
    -10.4 ( 0.99 )
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.7
         upper limit
    		 -6.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.31
    Notes
    [3] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.

    Secondary: Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score

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    End point title
    		 Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
    End point description
    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. Analysis Population Description: mITT Population
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    151
    150
    Units: score on a scale
    least squares mean (standard error)
        Week 5 (n = 148, 127)
    -2.7 ( 0.67 )
    -5.2 ( 0.72 )
        Week 8 (n = 145, 119)
    -3.2 ( 0.73 )
    -8.3 ( 0.79 )
        Week 11 (n = 141, 111)
    -3.2 ( 0.82 )
    -9.3 ( 0.89 )
        Week 14 (n = 140, 110)
    -3.0 ( 0.88 )
    -10.4 ( 0.96 )
        Week 18 (n = 138, 107)
    -2.9 ( 0.96 )
    -10.1 ( 1.05 )
        Week 22 (n = 137, 99)
    -1.8 ( 0.96 )
    -10.1 ( 1.07 )
        Week 26 (n = 133, 99)
    -1.6 ( 1.03 )
    -9.9 ( 1.15 )
        Week 27 (n = 134, 100)
    -1.8 ( 1.03 )
    -10.2 ( 1.14 )
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -8.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.3
         upper limit
    		 -5.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.52
    Notes
    [4] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.

    Secondary: Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score

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    End point title
    		 Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
    End point description
    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. Analysis Population Description: mITT Population
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    151
    150
    Units: score on a scale
    least squares mean (standard error)
        Part I: Week 5 (n = 148, 127)
    -0.6 ( 0.23 )
    0.4 ( 0.25 )
        Part I: Week 8 (n = 146, 120)
    -0.8 ( 0.25 )
    0.2 ( 0.27 )
        Part I: Week 11 (n = 141, 111)
    -0.8 ( 0.25 )
    0.2 ( 0.27 )
        Part I: Week 14 (n = 141, 111)
    -0.7 ( 0.25 )
    -0.1 ( 0.27 )
        Part I: Week 18 (n = 138, 107)
    -0.7 ( 0.25 )
    -0.2 ( 0.27 )
        Part I: Week 22 (n = 137, 99)
    -0.5 ( 0.27 )
    0.0 ( 0.30 )
        Part I: Week 26 (n = 134, 99)
    -0.4 ( 0.29 )
    0.3 ( 0.32 )
        Part I: Week 27 (n = 134, 100)
    -0.6 ( 0.28 )
    0.2 ( 0.31 )
        Part II: Week 5 (n = 148, 127)
    -0.6 ( 0.22 )
    -1.0 ( 0.24 )
        Part II: Week 8 (n = 146, 120)
    -0.4 ( 0.23 )
    -1.5 ( 0.25 )
        Part II: Week 11 (n = 141, 111)
    -0.2 ( 0.26 )
    -1.4 ( 0.28 )
        Part II: Week 14 (n = 141, 111)
    -0.4 ( 0.26 )
    -1.7 ( 0.29 )
        Part II: Week 18 (n = 138, 107)
    -0.3 ( 0.27 )
    -1.5 ( 0.30 )
        Part II: Week 22 (n = 137, 99)
    0.2 ( 0.29 )
    -1.4 ( 0.32 )
        Part II: Week 26 (n = 134, 99)
    0.0 ( 0.30 )
    -1.5 ( 0.33 )
        Part II: Week 27 (n = 134, 100)
    0.0 ( 0.30 )
    -1.3 ( 0.34 )
        Part III: Week 5 (n = 148, 127)
    -1.5 ( 0.48 )
    -4.5 ( 0.52 )
        Part III: Week 8 (n = 145, 119)
    -2.0 ( 0.53 )
    -7.0 ( 0.58 )
        Part III: Week 11 (n = 141, 111)
    -2.2 ( 0.58 )
    -8.1 ( 0.64 )
        Part III: Week 14 (n = 140, 110)
    -1.9 ( 0.63 )
    -8.6 ( 0.69 )
        Part III: Week 18 (n = 138, 107)
    -1.9 ( 0.69 )
    -8.4 ( 0.77 )
        Part III: Week 22 (n = 137, 99)
    -1.5 ( 0.68 )
    -8.7 ( 0.76 )
        Part III: Week 26 (n = 133, 99)
    -1.2 ( 0.71 )
    -8.9 ( 0.80 )
        Part III: Week 27 (n = 134, 100)
    -1.2 ( 0.71 )
    -9.0 ( 0.80 )
    Statistical analysis title
    		 Part I: Week 26 - Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0766 [5]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.42
    Notes
    [5] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.
    Statistical analysis title
    		 Part II: Week 26 - Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007 [6]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 -0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.44
    Notes
    [6] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.
    Statistical analysis title
    		 Part III: Week 26 - Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 -5.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.05
    Notes
    [7] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.

    Secondary: Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score

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    End point title
    		 Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
    End point description
    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. Analysis Population Description: mITT Population
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    151
    150
    Units: score on a scale
    least squares mean (standard error)
        Week 5 (n = 147, 126)
    0.0 ( 0.04 )
    -0.2 ( 0.05 )
        Week 8 (n = 145, 119)
    0.0 ( 0.05 )
    -0.2 ( 0.05 )
        Week 11 (n = 141, 110)
    0.0 ( 0.05 )
    -0.3 ( 0.06 )
        Week 14 (n = 140, 110)
    0.0 ( 0.05 )
    -0.3 ( 0.05 )
        Week 18 (n = 138, 106)
    0.0 ( 0.05 )
    -0.3 ( 0.06 )
        Week 22 (n = 137, 98)
    0.0 ( 0.05 )
    -0.4 ( 0.06 )
        Week 26 (n = 134, 98)
    0.0 ( 0.06 )
    -0.4 ( 0.06 )
        Week 27 (n = 134, 99)
    0.0 ( 0.05 )
    -0.3 ( 0.06 )
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Notes
    [8] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.

    Secondary: Clinical Global Impression - Improvement (CGI-I) Score

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    End point title
    		 Clinical Global Impression - Improvement (CGI-I) Score
    End point description
    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. Analysis Population Description: mITT Population
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    151
    150
    Units: units on a scale
    least squares mean (standard error)
        Week 5 (n = 148, 127)
    3.6 ( 0.06 )
    3.3 ( 0.07 )
        Week 8 (n = 146, 120)
    3.5 ( 0.07 )
    3.1 ( 0.08 )
        Week 11 (n = 141, 111)
    3.5 ( 0.08 )
    3.0 ( 0.09 )
        Week 14 (n = 140, 111)
    3.6 ( 0.08 )
    2.9 ( 0.09 )
        Week 18 (n = 138, 107)
    3.7 ( 0.09 )
    2.8 ( 0.10 )
        Week 22 (n = 137, 99)
    3.6 ( 0.09 )
    2.8 ( 0.10 )
        Week 26 (n = 134, 99)
    3.7 ( 0.10 )
    2.7 ( 0.11 )
        Week 27 (n = 134, 100)
    3.7 ( 0.09 )
    2.8 ( 0.11 )
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [9]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [9] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.

    Secondary: Change From Baseline in the PGIC Score

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    End point title
    		 Change From Baseline in the PGIC Score
    End point description
    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. Analysis Population Description: mITT Population
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    151
    150
    Units: score on a scale
    least squares mean (standard error)
        Week 5 (n = 148, 127)
    3.5 ( 0.08 )
    3.3 ( 0.09 )
        Week 8 (n = 145, 120)
    3.6 ( 0.09 )
    3.1 ( 0.09 )
        Week 11 (n = 140, 111)
    3.6 ( 0.09 )
    3.1 ( 0.10 )
        Week 14 (n = 141, 111)
    3.6 ( 0.10 )
    2.9 ( 0.11 )
        Week 18 (n = 138, 107)
    3.7 ( 0.10 )
    2.9 ( 0.12 )
        Week 22 (n = 137, 99)
    3.7 ( 0.10 )
    2.9 ( 0.12 )
        Week 26 (n = 134, 99)
    3.8 ( 0.11 )
    2.8 ( 0.12 )
        Week 27 (n = 134, 100)
    3.8 ( 0.11 )
    2.8 ( 0.12 )
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16

    Secondary: Epworth Sleepiness Scale (ESS)

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    End point title
    		 Epworth Sleepiness Scale (ESS)
    End point description
    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. Analysis Population Description: FAS population includes all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    134
    98
    Units: score on a scale
        least squares mean (standard error)
    -0.1 ( 0.22 )
    -0.1 ( 0.24 )
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9795 [10]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.32
    Notes
    [10] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.

    Secondary: Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)

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    End point title
    		 Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)
    End point description
    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. Analysis Population Description: FAS population
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    134
    99
    Units: score on a scale
        least squares mean (standard error)
    -1.9 ( 0.31 )
    -2.0 ( 0.34 )
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8916 [11]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.45
    Notes
    [11] - LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.

    Secondary: Columbia-Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Columbia-Suicide Severity Rating Scale (C-SSRS)
    End point description
    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. Analysis Population Description: FAS population
    End point type
    Secondary
    End point timeframe
    Week 27
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    153
    151
    Units: participants
        Any Suicidal Ideations
    0
    5
        Any Suicidal Behaviors
    0
    0
        Any Suicidal Behaviors or Ideations
    0
    5
        Non-Suicidal Self-Injurious Behavior
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs)
    End point description
    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. Analysis Population Description: FAS Population
    End point type
    Secondary
    End point timeframe
    From first dose of study drug until 190 days following last dose of study drug.
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    153
    151
    Units: participants
        Any TEAE
    84
    115
        TESAE
    2
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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.
    Adverse event reporting additional description
    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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Tavapadon_5_to_15_mg_QD
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Tavapadon_5_to_15_mg_QD Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 151 (4.64%)
    2 / 153 (1.31%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEAD INJURY
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FALL
         subjects affected / exposed
    2 / 151 (1.32%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JOINT INJURY
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    PRESYNCOPE
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    REVERSIBLE CEREBRAL VASOCONSTRICTION SYNDROME
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    HYPERCHROMIC ANAEMIA
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    HYPERHIDROSIS
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    DEPRESSION
         subjects affected / exposed
    1 / 151 (0.66%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Tavapadon_5_to_15_mg_QD Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    99 / 151 (65.56%)
    59 / 153 (38.56%)
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    8 / 151 (5.30%)
    3 / 153 (1.96%)
         occurrences all number
    10
    4
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    6 / 151 (3.97%)
    0 / 153 (0.00%)
         occurrences all number
    7
    0
    Nervous system disorders
    PARAESTHESIA
         subjects affected / exposed
    4 / 151 (2.65%)
    4 / 153 (2.61%)
         occurrences all number
    5
    5
    HEADACHE
         subjects affected / exposed
    25 / 151 (16.56%)
    8 / 153 (5.23%)
         occurrences all number
    37
    11
    DYSGEUSIA
         subjects affected / exposed
    12 / 151 (7.95%)
    0 / 153 (0.00%)
         occurrences all number
    12
    0
    DIZZINESS
         subjects affected / exposed
    24 / 151 (15.89%)
    5 / 153 (3.27%)
         occurrences all number
    28
    7
    TREMOR
         subjects affected / exposed
    3 / 151 (1.99%)
    13 / 153 (8.50%)
         occurrences all number
    3
    15
    SOMNOLENCE
         subjects affected / exposed
    5 / 151 (3.31%)
    6 / 153 (3.92%)
         occurrences all number
    6
    7
    PARKINSON'S DISEASE
         subjects affected / exposed
    1 / 151 (0.66%)
    4 / 153 (2.61%)
         occurrences all number
    1
    4
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    8 / 151 (5.30%)
    2 / 153 (1.31%)
         occurrences all number
    9
    2
    FATIGUE
         subjects affected / exposed
    12 / 151 (7.95%)
    1 / 153 (0.65%)
         occurrences all number
    14
    1
    Gastrointestinal disorders
    DYSPEPSIA
         subjects affected / exposed
    6 / 151 (3.97%)
    2 / 153 (1.31%)
         occurrences all number
    6
    3
    CONSTIPATION
         subjects affected / exposed
    6 / 151 (3.97%)
    3 / 153 (1.96%)
         occurrences all number
    6
    3
    DIARRHOEA
         subjects affected / exposed
    4 / 151 (2.65%)
    2 / 153 (1.31%)
         occurrences all number
    5
    2
    DRY MOUTH
         subjects affected / exposed
    5 / 151 (3.31%)
    1 / 153 (0.65%)
         occurrences all number
    5
    1
    VOMITING
         subjects affected / exposed
    12 / 151 (7.95%)
    0 / 153 (0.00%)
         occurrences all number
    14
    0
    SALIVARY HYPERSECRETION
         subjects affected / exposed
    5 / 151 (3.31%)
    2 / 153 (1.31%)
         occurrences all number
    5
    2
    NAUSEA
         subjects affected / exposed
    45 / 151 (29.80%)
    5 / 153 (3.27%)
         occurrences all number
    54
    5
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    6 / 151 (3.97%)
    2 / 153 (1.31%)
         occurrences all number
    7
    2
    Psychiatric disorders
    ABNORMAL DREAMS
         subjects affected / exposed
    5 / 151 (3.31%)
    1 / 153 (0.65%)
         occurrences all number
    5
    2
    INSOMNIA
         subjects affected / exposed
    6 / 151 (3.97%)
    5 / 153 (3.27%)
         occurrences all number
    6
    5
    ANXIETY
         subjects affected / exposed
    5 / 151 (3.31%)
    2 / 153 (1.31%)
         occurrences all number
    5
    2
    Musculoskeletal and connective tissue disorders
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 151 (0.00%)
    4 / 153 (2.61%)
         occurrences all number
    0
    5
    BACK PAIN
         subjects affected / exposed
    4 / 151 (2.65%)
    7 / 153 (4.58%)
         occurrences all number
    5
    8
    ARTHRALGIA
         subjects affected / exposed
    7 / 151 (4.64%)
    6 / 153 (3.92%)
         occurrences all number
    7
    6
    Infections and infestations
    URINARY TRACT INFECTION
         subjects affected / exposed
    5 / 151 (3.31%)
    4 / 153 (2.61%)
         occurrences all number
    5
    4
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 151 (1.99%)
    7 / 153 (4.58%)
         occurrences all number
    3
    7
    COVID-19
         subjects affected / exposed
    5 / 151 (3.31%)
    8 / 153 (5.23%)
         occurrences all number
    5
    8
    BRONCHITIS
         subjects affected / exposed
    0 / 151 (0.00%)
    4 / 153 (2.61%)
         occurrences all number
    0
    4
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    4 / 151 (2.65%)
    1 / 153 (0.65%)
         occurrences all number
    4
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2020
    Version 2.0: Incorporate measures into the protocol to ensure the safety of the trial subjects and the validity of the trial data in the environment of the COVID-19 pandemic and to clarify other aspects of trial conduct unrelated to the COVID-19 pandemic.
    03 Sep 2021
    Version 3.0: Correct errors and harmonize similar content across the Phase 3 tavapadon protocols via modification and clarification of eligibility criteria, procedural aspects, and statistical considerations.
    06 Jul 2023
    Version 4.0: Add eye examinations as an additional trial assessment to monitor for the new potential risk of increased intraocular pressure across the Phase 3 tavapadon protocols.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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