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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 of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)

    Summary
    EudraCT number
    		 2019-002949-38
    Trial protocol
    		 HU   CZ   DE   FR   PL   ES   BG   IT  
    Global end of trial date
    28 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2025
    First version publication date
    26 Jun 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CVL-751-PD-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04201093
    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
    28 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.
    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
    13 Dec 2019
    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
    Australia: 37
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    Israel: 32
    Country: Number of subjects enrolled
    Ukraine: 15
    Country: Number of subjects enrolled
    United States: 158
    Country: Number of subjects enrolled
    Poland: 28
    Country: Number of subjects enrolled
    Spain: 39
    Country: Number of subjects enrolled
    Bulgaria: 93
    Country: Number of subjects enrolled
    Czechia: 32
    Country: Number of subjects enrolled
    France: 43
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Italy: 21
    Worldwide total number of subjects
    529
    EEA total number of subjects
    278
    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)
    254
    From 65 to 84 years
    275
    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 529 subjects with Parkinson’s Disease (PD) were be randomized in a 1:1:1 ratio to 3 treatment groups: Tavapadon 5 mg, Tavapadon 15 mg, or Placebo 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
    		 Participants will receive placebo matching to tavapadon tablet 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 5 mg
    Arm description
    		 Subjects will receive tavapadon tablet titrated up to 5 milligram (mg) once daily (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 will receive tavapadon tablet titrated up to either 5 milligram (mg) or 15 mg (based on Arm) once daily (QD) orally for 27 weeks.

    Arm title
    		 Tavapadon 15 mg
    Arm description
    		 Subjects will receive tavapadon tablet titrated up to 15 milligram (mg) 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 will receive tavapadon tablet titrated up to either 5 milligram (mg) or 15 mg (based on Arm) once daily (QD) orally for 27 weeks.

    Number of subjects in period 1
    		Placebo Tavapadon 5 mg Tavapadon 15 mg
    Started
    175
    177
    177
    Completed
    148
    134
    118
    Not completed
    27
    43
    59
         Treatment with Prohibited Concomitant Medications
    -
    -
    1
         Consent withdrawn by subject
    7
    8
    15
         Physician decision
    1
    -
    -
         Failure to Meet Continuation Criteria
    -
    -
    1
         Adverse event, non-fatal
    6
    29
    35
         Death
    2
    1
    -
         Other
    -
    1
    2
         Non- Compliance with Study Schedule
    -
    -
    1
         Site Terminated by Sponsor
    5
    3
    1
         Lost to follow-up
    -
    -
    1
         Lack of efficacy
    5
    1
    2
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.

    Reporting group title
    Tavapadon 5 mg
    Reporting group description
    		 Subjects will receive tavapadon tablet titrated up to 5 milligram (mg) once daily (QD) orally for 27 weeks.

    Reporting group title
    Tavapadon 15 mg
    Reporting group description
    		 Subjects will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.

    Reporting group values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg Total
    Number of subjects
    		 175 177 177 529
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.5 ( 9.62 ) 63.7 ( 9.80 ) 63.8 ( 9.40 ) -
    Gender categorical
    Units: Subjects
        Female
    		 63 66 58 187
        Male
    		 112 111 119 342
    Ethnicity (NIH/ OMB)
    Units: Subjects
        Hispanic or Latino
    		 9 13 10 32
        Not Hispanic or Latino
    		 154 153 158 465
        Unknown or Not Reported
    		 12 11 9 32
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 0 1
        Asian
    		 1 0 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 1
        Black or African American
    		 3 0 2 5
        White
    		 168 174 172 514
        More than one race
    		 0 1 0 1
        Unknown or Not Reported
    		 2 1 2 5
    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. 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.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 32.0 ( 9.96 ) 31.3 ( 10.87 ) 32.1 ( 11.55 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.

    Reporting group title
    Tavapadon 5 mg
    Reporting group description
    		 Subjects will receive tavapadon tablet titrated up to 5 milligram (mg) once daily (QD) orally for 27 weeks.

    Reporting group title
    Tavapadon 15 mg
    Reporting group description
    		 Subjects will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.

    Primary: 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.
    End point type
    Primary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    148
    132
    116
    Units: score on a scale
        least squares mean (standard error)
    1.8 ( 0.82 )
    -9.7 ( 0.86 )
    -10.2 ( 0.88 )
    Statistical analysis title
    		 Placebo, Tavapadon 5 mg
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    280
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -11.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.8
         upper limit
    		 -9.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.16
    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.
    Statistical analysis title
    		 Placebo, Tavapadon 15 mg
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    264
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 -9.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.17
    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: 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.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    148
    132
    116
    Units: score on a scale
        least squares mean (standard error)
    0.9 ( 0.30 )
    -1.6 ( 0.31 )
    -1.7 ( 0.32 )
    Statistical analysis title
    		 Placebo, Tavapadon 5 mg
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    280
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.43
    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.
    Statistical analysis title
    		 Placebo, Tavapadon 15 mg
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    264
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 -1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.43
    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: Percentage of Responders With a Score of "Much Improved" or "Very Much Improved" on PGIC

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    End point title
    		 Percentage of Responders With a Score of "Much Improved" or "Very Much Improved" on 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.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    147
    132
    117
    Units: Count of Participants
    18
    60
    52
    Statistical analysis title
    		 Placebo, Tavapadon 5 mg
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.148
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.339
         upper limit
    		 11.321
    Statistical analysis title
    		 Placebo, Tavapadon 15 mg
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    264
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.968
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.22
         upper limit
    		 11.062

    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.
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    174 [5]
    174 [6]
    172 [7]
    Units: score on a scale
    least squares mean (standard error)
        Week 5
    -1.2 ( 0.57 )
    -4.4 ( 0.59 )
    -4.7 ( 0.59 )
        Week 8
    -2.2 ( 0.62 )
    -6.9 ( 0.65 )
    -6.7 ( 0.65 )
        Week 11
    -0.9 ( 0.72 )
    -8.1 ( 0.75 )
    -9.1 ( 0.75 )
        Week 14
    -1.2 ( 0.74 )
    -8.8 ( 0.78 )
    -9.4 ( 0.78 )
        Week 18
    0.4 ( 0.78 )
    -9.1 ( 0.82 )
    -9.7 ( 0.83 )
        Week 22
    0.4 ( 0.81 )
    -9.6 ( 0.84 )
    -10.9 ( 0.86 )
        Week 26
    1.8 ( 0.82 )
    -9.7 ( 0.86 )
    -10.2 ( 0.88 )
        Week 27
    2.2 ( 0.92 )
    -8.6 ( 0.96 )
    -10.0 ( 0.99 )
    Notes
    [5] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 171, 168, 160, 158, 153, 150, 148, and 148, respectively.
    [6] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 154, 147, 138, 142, 138, 137, 132, and 134, respectively.
    [7] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 159, 150, 135, 134, 129, 126, 116, and 119, respectively.
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon 5 mg
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    348
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -11.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.8
         upper limit
    		 -9.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.16
    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.
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon 15 mg
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [9]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 -9.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.17
    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 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
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    174 [10]
    174 [11]
    172 [12]
    Units: score on a scale
    least squares mean (standard error)
        Week 5
    -1.2 ( 0.67 )
    -3.9 ( 0.69 )
    -4.0 ( 0.69 )
        Week 8
    -2.6 ( 0.72 )
    -6.4 ( 0.76 )
    -6.2 ( 0.75 )
        Week 11
    -1.2 ( 0.81 )
    -7.7 ( 0.86 )
    -8.6 ( 0.86 )
        Week 14
    -1.5 ( 0.85 )
    -8.8 ( 0.89 )
    -8.7 ( 0.90 )
        Week 18
    0.3 ( 0.91 )
    -9.3 ( 0.95 )
    -9.1 ( 0.96 )
        Week 22
    0.2 ( 0.94 )
    -9.5 ( 0.98 )
    -10.3 ( 1.00 )
        Week 26
    2.3 ( 0.95 )
    -9.4 ( 1.00 )
    -9.7 ( 1.02 )
        Week 27
    2.4 ( 1.06 )
    -8.5 ( 1.11 )
    -9.4 ( 1.14 )
    Notes
    [10] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 171, 168, 160, 158, 153, 150, 148, and 148, respectively.
    [11] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 154, 147, 138, 142, 138, 137, 132, and 134, respectively.
    [12] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 159, 150, 135, 134, 129, 126, 116, and 119, respectively.
    Statistical analysis title
    		 Placebo, Tavapadon 5 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    348
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [13]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -11.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 -9.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.35
    Notes
    [13] - 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
    		 Placebo, Tavapadon 15 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [14]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.7
         upper limit
    		 -9.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.37
    Notes
    [14] - 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. For Weeks 5, 8, 11, 14, 18, 22, 26, and 27: Part I: N = 171, 168, 161, 158, 153, 150, 148, and 148, respectively. Part II: N = 171, 168, 161, 159, 153, 150, 148, and 148, respectively. Part III: N = 171, 168, 160, 158, 153, 150, 148, and 148, respectively.
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    174 [15]
    174 [16]
    172 [17]
    Units: score on a scale
    least squares mean (standard error)
        Part I: Week 5
    0.0 ( 0.23 )
    0.6 ( 0.24 )
    0.7 ( 0.24 )
        Part I: Week 8
    -0.4 ( 0.23 )
    0.5 ( 0.24 )
    0.4 ( 0.24 )
        Part I: Week 11
    -0.3 ( 0.23 )
    0.4 ( 0.24 )
    0.4 ( 0.25 )
        Part I: Week 14
    -0.2 ( 0.25 )
    0.0 ( 0.27 )
    0.6 ( 0.27 )
        Part I: Week 18
    -0.1 ( 0.25 )
    -0.2 ( 0.26 )
    0.5 ( 0.27 )
        Part I: Week 22
    -0.2 ( 0.26 )
    0.2 ( 0.27 )
    0.4 ( 0.28 )
        Part I: Week 26
    0.5 ( 0.27 )
    0.2 ( 0.28 )
    0.4 ( 0.29 )
        Part I: Week 27
    0.2 ( 0.27 )
    0.2 ( 0.28 )
    0.3 ( 0.29 )
        Part II: Week 5
    -0.2 ( 0.22 )
    -0.8 ( 0.23 )
    -1.0 ( 0.22 )
        Part II: Week 8
    -0.5 ( 0.23 )
    -1.0 ( 0.25 )
    -1.6 ( 0.24 )
        Part II: Week 11
    0.0 ( 0.26 )
    -1.7 ( 0.27 )
    -2.0 ( 0.27 )
        Part II: Week 14
    -0.1 ( 0.27 )
    -1.6 ( 0.28 )
    -2.0 ( 0.28 )
        Part II: Week 18
    0.4 ( 0.29 )
    -1.9 ( 0.31 )
    -1.8 ( 0.31 )
        Part II: Week 22
    0.3 ( 0.28 )
    -1.7 ( 0.29 )
    -2.1 ( 0.29 )
        Part II: Week 26
    0.9 ( 0.30 )
    -1.6 ( 0.31 )
    -1.7 ( 0.32 )
        Part II: Week 27
    0.9 ( 0.31 )
    -1.7 ( 0.32 )
    -1.8 ( 0.33 )
        Part III: Week 5
    -1.0 ( 0.44 )
    -3.7 ( 0.46 )
    -3.7 ( 0.45 )
        Part III: Week 8
    -1.7 ( 0.50 )
    -6.0 ( 0.52 )
    -5.1 ( 0.52 )
        Part III: Week 11
    -1.0 ( 0.55 )
    -6.5 ( 0.58 )
    -7.1 ( 0.59 )
        Part III: Week 14
    -1.1 ( 0.58 )
    -7.2 ( 0.61 )
    -7.4 ( 0.61 )
        Part III: Week 18
    0.0 ( 0.60 )
    -7.3 ( 0.63 )
    -7.9 ( 0.64 )
        Part III: Week 22
    0.0 ( 0.64 )
    -8.0 ( 0.67 )
    -8.8 ( 0.68 )
        Part III: Week 26
    0.9 ( 0.63 )
    -8.1 ( 0.66 )
    -8.5 ( 0.68 )
        Part III: Week 27
    1.1 ( 0.71 )
    -7.1 ( 0.75 )
    -8.3 ( 0.77 )
    Notes
    [15] - N values vary per part and week, see End Point description for each specific N.
    [16] - N values vary per part and week, see End Point description for each specific N.
    [17] - N values vary per part and week, see End Point description for each specific N.
    Statistical analysis title
    		 Part I: Week 26 - Placebo, Tavapadon 5 mg
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    348
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4822 [18]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.38
    Notes
    [18] - 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 I: Week 26 - Placebo, Tavapadon 15 mg
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7742 [19]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.38
    Notes
    [19] - 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 5 mg
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    348
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [20]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.43
    Notes
    [20] - 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 15 mg
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [21]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 -1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.43
    Notes
    [21] - 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 5 mg
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    348
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [22]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.8
         upper limit
    		 -7.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.89
    Notes
    [22] - 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 15 mg
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [23]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -9.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.2
         upper limit
    		 -7.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.9
    Notes
    [23] - 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 CGI-S Score

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    End point title
    		 Change From Baseline in the 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.
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    174 [24]
    174 [25]
    172 [26]
    Units: score on a scale
    least squares mean (standard error)
        Week 5
    0.0 ( 0.04 )
    -0.1 ( 0.05 )
    0.0 ( 0.05 )
        Week 8
    0.0 ( 0.05 )
    -0.1 ( 0.05 )
    -0.1 ( 0.05 )
        Week 11
    0.0 ( 0.05 )
    -0.2 ( 0.05 )
    -0.3 ( 0.05 )
        Week 14
    0.1 ( 0.05 )
    -0.2 ( 0.05 )
    -0.3 ( 0.05 )
        Week 18
    0.1 ( 0.05 )
    -0.3 ( 0.06 )
    -0.3 ( 0.06 )
        Week 22
    0.1 ( 0.05 )
    -0.2 ( 0.06 )
    -0.3 ( 0.06 )
        Week 26
    0.2 ( 0.05 )
    -0.3 ( 0.05 )
    -0.2 ( 0.06 )
        Week 27
    0.1 ( 0.05 )
    -0.2 ( 0.06 )
    -0.2 ( 0.06 )
    Notes
    [24] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 171, 168, 161, 158, 153, 150, 148, and 147, respectively.
    [25] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 155, 148, 141, 141, 138, 137, 132, and 134, respectively.
    [26] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 160, 151, 135, 133, 129, 126, 117, and 119, respectively.
    Statistical analysis title
    		 Placebo, Tavapadon 5 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Tavapadon 5 mg v Placebo
    Number of subjects included in analysis
    348
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [27]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Notes
    [27] - 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
    		 Placebo, Tavapadon 15 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [28]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (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
    0.07
    Notes
    [28] - 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 CGI-I Score

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    End point title
    		 Change From Baseline in the 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.
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    174 [29]
    174 [30]
    172 [31]
    Units: score on a scale
    least squares mean (standard error)
        Week 5
    3.8 ( 0.06 )
    3.4 ( 0.06 )
    3.4 ( 0.06 )
        Week 8
    3.8 ( 0.06 )
    3.2 ( 0.07 )
    3.3 ( 0.07 )
        Week 11
    3.8 ( 0.07 )
    3.0 ( 0.08 )
    3.1 ( 0.08 )
        Week 14
    3.8 ( 0.07 )
    3.0 ( 0.08 )
    3.0 ( 0.08 )
        Week 18
    3.9 ( 0.08 )
    2.8 ( 0.08 )
    2.9 ( 0.08 )
        Week 22
    3.9 ( 0.08 )
    2.9 ( 0.09 )
    3.0 ( 0.09 )
        Week 26
    3.9 ( 0.09 )
    2.8 ( 0.09 )
    3.0 ( 0.09 )
        Week 27
    4.0 ( 0.09 )
    2.8 ( 0.09 )
    2.9 ( 0.09 )
    Notes
    [29] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 171, 167, 160, 158, 153, 150, 148, and 147, respectively.
    [30] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 154, 148, 141, 142, 138, 136, 132, and 134, respectively.
    [31] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 160, 150, 134, 134, 128, 126, 117, and 119, respectively.
    Statistical analysis title
    		 Placebo, Tavapadon 5 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    348
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [32]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [32] - 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
    		 Placebo, Tavapadon 15 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [33]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [33] - 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.
    End point type
    Secondary
    End point timeframe
    Week 5, 8, 11, 14, 18, 22, 26, and 27
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    174 [34]
    174 [35]
    172 [36]
    Units: score on a scale
    least squares mean (standard error)
        Week 5
    3.7 ( 0.07 )
    3.5 ( 0.07 )
    3.4 ( 0.07 )
        Week 8
    3.8 ( 0.08 )
    3.2 ( 0.08 )
    3.2 ( 0.08 )
        Week 11
    3.8 ( 0.08 )
    3.0 ( 0.08 )
    3.1 ( 0.08 )
        Week 14
    3.8 ( 0.08 )
    2.8 ( 0.09 )
    3.0 ( 0.09 )
        Week 18
    3.9 ( 0.09 )
    2.8 ( 0.10 )
    2.9 ( 0.10 )
        Week 22
    3.8 ( 0.09 )
    2.9 ( 0.10 )
    2.9 ( 0.10 )
        Week 26
    4.0 ( 0.10 )
    2.8 ( 0.10 )
    2.8 ( 0.11 )
        Week 27
    4.0 ( 0.10 )
    2.8 ( 0.11 )
    2.9 ( 0.11 )
    Notes
    [34] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 171, 168, 161, 159, 154, 151, 147, and 147, respectively.
    [35] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 155, 148, 141, 142, 137, 137, 132, and 134, respectively.
    [36] - Wk 5, 8, 11, 14, 18, 22, 26, and 27, N = 160, 151, 135, 134, 129, 126, 117, and 119, respectively.
    Statistical analysis title
    		 Placebo, Tavapadon 5 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Tavapadon 5 mg v Placebo
    Number of subjects included in analysis
    348
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [37]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [37] - 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
    		 Placebo, Tavapadon 15 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [38]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [38] - 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 Epworth Sleepiness Scale (ESS)

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    End point title
    		 Change From Baseline in the 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.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    148
    134
    118
    Units: score on a scale
        least squares mean (standard error)
    -0.2 ( 0.23 )
    -0.3 ( 0.24 )
    -0.5 ( 0.24 )
    Statistical analysis title
    		 Placebo, Tavapadon 5 mg
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6047 [39]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.32
    Notes
    [39] - 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
    		 Placebo, Tavapadon 15 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    266
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.257 [40]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.33
    Notes
    [40] - 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 Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)

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    End point title
    		 Change From Baseline in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)
    End point description
    QUIP-RS is a global screening instrument that assesses impulse control disorders (ICDs) and related disorders (punding, hobbyism, and dopamine dysregulation syndrome) in participants with PD. 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.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    147
    134
    118
    Units: score on a scale
        least squares mean (standard error)
    -2.1 ( 0.46 )
    -2.2 ( 0.47 )
    -2.4 ( 0.48 )
    Statistical analysis title
    		 Placebo, Tavapadon 5 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tavapadon 5 mg
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8516 [41]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.63
    Notes
    [41] - 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
    		 Placebo, Tavapadon 15 mg
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tavapadon 15 mg
    Number of subjects included in analysis
    265
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6421 [42]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.64
    Notes
    [42] - 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.
    End point type
    Secondary
    End point timeframe
    Week 27
    End point values
    		 Placebo Tavapadon 5 mg Tavapadon 15 mg
    Number of subjects analysed
    175
    177
    177
    Units: Count of Participants
        Participants With Any Suicidal Ideations
    3
    3
    3
        Participants With Any Suicidal Behaviors
    0
    0
    0
        Participants With Any Suicidal Behaviors or Ideati
    3
    3
    3
        Participants With Non-Suicidal Self-Injurious Beha
    0
    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.
    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 5 mg Tavapadon 15 mg
    Number of subjects analysed
    175
    177
    177
    Units: Participants
    100
    142
    139
    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 to the end of study, median time on follow up (median time subjects were followed) was 190,190, and 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
    Adverse event reporting additional description
    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 for all Arms; mean duration on study drug was 27 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Tavapadon_15_mg_QD
    Reporting group description
    		 -

    Reporting group title
    Tavapadon_5_mg_QD
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Tavapadon_15_mg_QD Tavapadon_5_mg_QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 175 (6.29%)
    10 / 177 (5.65%)
    4 / 177 (2.26%)
         number of deaths (all causes)
    2
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BASAL CELL CARCINOMA
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 177 (0.00%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PROSTATE CANCER
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 177 (0.00%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RENAL CELL CARCINOMA
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 177 (0.00%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 177 (0.00%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    FEMUR FRACTURE
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 177 (0.00%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HEAD INJURY
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 177 (0.00%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RADIUS FRACTURE
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 177 (0.56%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    THROMBOSIS
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 177 (0.56%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ANGINA UNSTABLE
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 177 (0.56%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CORONARY ARTERY STENOSIS
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 177 (0.56%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 177 (0.00%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 177 (0.56%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 177 (0.56%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    DEATH
         subjects affected / exposed
    0 / 175 (0.00%)
    0 / 177 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    PERIPHERAL SWELLING
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 177 (0.56%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    0 / 175 (0.00%)
    0 / 177 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    1 / 175 (0.57%)
    0 / 177 (0.00%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    PROSTATOMEGALY
         subjects affected / exposed
    0 / 175 (0.00%)
    0 / 177 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    HALLUCINATION, TACTILE
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 177 (0.56%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    1 / 175 (0.57%)
    2 / 177 (1.13%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 PNEUMONIA
         subjects affected / exposed
    2 / 175 (1.14%)
    0 / 177 (0.00%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    3 / 175 (1.71%)
    0 / 177 (0.00%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    TRACHEOBRONCHITIS
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 177 (0.56%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Tavapadon_15_mg_QD Tavapadon_5_mg_QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 175 (41.14%)
    125 / 177 (70.62%)
    125 / 177 (70.62%)
    Investigations
    SARS-COV-2 TEST POSITIVE
         subjects affected / exposed
    2 / 175 (1.14%)
    0 / 177 (0.00%)
    4 / 177 (2.26%)
         occurrences all number
    2
    0
    4
    WEIGHT DECREASED
         subjects affected / exposed
    2 / 175 (1.14%)
    4 / 177 (2.26%)
    3 / 177 (1.69%)
         occurrences all number
    2
    4
    4
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    6 / 175 (3.43%)
    7 / 177 (3.95%)
    4 / 177 (2.26%)
         occurrences all number
    6
    8
    4
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    4 / 175 (2.29%)
    8 / 177 (4.52%)
    7 / 177 (3.95%)
         occurrences all number
    4
    9
    9
    HYPERTENSION
         subjects affected / exposed
    8 / 175 (4.57%)
    2 / 177 (1.13%)
    1 / 177 (0.56%)
         occurrences all number
    8
    2
    1
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    0 / 175 (0.00%)
    4 / 177 (2.26%)
    11 / 177 (6.21%)
         occurrences all number
    0
    4
    11
    Nervous system disorders
    PAROSMIA
         subjects affected / exposed
    0 / 175 (0.00%)
    4 / 177 (2.26%)
    4 / 177 (2.26%)
         occurrences all number
    0
    4
    4
    PARAESTHESIA
         subjects affected / exposed
    1 / 175 (0.57%)
    8 / 177 (4.52%)
    3 / 177 (1.69%)
         occurrences all number
    1
    11
    5
    HYPOAESTHESIA
         subjects affected / exposed
    2 / 175 (1.14%)
    6 / 177 (3.39%)
    3 / 177 (1.69%)
         occurrences all number
    2
    9
    4
    HEADACHE
         subjects affected / exposed
    9 / 175 (5.14%)
    37 / 177 (20.90%)
    22 / 177 (12.43%)
         occurrences all number
    16
    39
    25
    DYSGEUSIA
         subjects affected / exposed
    0 / 175 (0.00%)
    14 / 177 (7.91%)
    14 / 177 (7.91%)
         occurrences all number
    0
    17
    14
    DIZZINESS
         subjects affected / exposed
    8 / 175 (4.57%)
    21 / 177 (11.86%)
    24 / 177 (13.56%)
         occurrences all number
    9
    23
    32
    AGEUSIA
         subjects affected / exposed
    0 / 175 (0.00%)
    5 / 177 (2.82%)
    1 / 177 (0.56%)
         occurrences all number
    0
    6
    1
    TREMOR
         subjects affected / exposed
    2 / 175 (1.14%)
    3 / 177 (1.69%)
    4 / 177 (2.26%)
         occurrences all number
    3
    3
    4
    SOMNOLENCE
         subjects affected / exposed
    6 / 175 (3.43%)
    5 / 177 (2.82%)
    6 / 177 (3.39%)
         occurrences all number
    6
    5
    6
    General disorders and administration site conditions
    OEDEMA PERIPHERAL
         subjects affected / exposed
    0 / 175 (0.00%)
    1 / 177 (0.56%)
    4 / 177 (2.26%)
         occurrences all number
    0
    1
    5
    FATIGUE
         subjects affected / exposed
    6 / 175 (3.43%)
    16 / 177 (9.04%)
    10 / 177 (5.65%)
         occurrences all number
    6
    17
    11
    ASTHENIA
         subjects affected / exposed
    0 / 175 (0.00%)
    2 / 177 (1.13%)
    5 / 177 (2.82%)
         occurrences all number
    0
    2
    5
    Ear and labyrinth disorders
    TINNITUS
         subjects affected / exposed
    1 / 175 (0.57%)
    3 / 177 (1.69%)
    6 / 177 (3.39%)
         occurrences all number
    1
    3
    6
    VERTIGO
         subjects affected / exposed
    2 / 175 (1.14%)
    3 / 177 (1.69%)
    5 / 177 (2.82%)
         occurrences all number
    2
    3
    6
    Gastrointestinal disorders
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    1 / 175 (0.57%)
    4 / 177 (2.26%)
    7 / 177 (3.95%)
         occurrences all number
    1
    4
    7
    DYSPEPSIA
         subjects affected / exposed
    2 / 175 (1.14%)
    10 / 177 (5.65%)
    5 / 177 (2.82%)
         occurrences all number
    3
    10
    6
    ABDOMINAL PAIN
         subjects affected / exposed
    2 / 175 (1.14%)
    4 / 177 (2.26%)
    3 / 177 (1.69%)
         occurrences all number
    2
    4
    3
    DIARRHOEA
         subjects affected / exposed
    2 / 175 (1.14%)
    2 / 177 (1.13%)
    4 / 177 (2.26%)
         occurrences all number
    2
    3
    4
    CONSTIPATION
         subjects affected / exposed
    1 / 175 (0.57%)
    5 / 177 (2.82%)
    4 / 177 (2.26%)
         occurrences all number
    1
    5
    4
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 175 (0.00%)
    6 / 177 (3.39%)
    1 / 177 (0.56%)
         occurrences all number
    0
    8
    1
    DRY MOUTH
         subjects affected / exposed
    0 / 175 (0.00%)
    9 / 177 (5.08%)
    11 / 177 (6.21%)
         occurrences all number
    0
    9
    12
    VOMITING
         subjects affected / exposed
    1 / 175 (0.57%)
    9 / 177 (5.08%)
    12 / 177 (6.78%)
         occurrences all number
    2
    11
    13
    NAUSEA
         subjects affected / exposed
    3 / 175 (1.71%)
    48 / 177 (27.12%)
    42 / 177 (23.73%)
         occurrences all number
    5
    56
    44
    SALIVARY HYPERSECRETION
         subjects affected / exposed
    0 / 175 (0.00%)
    4 / 177 (2.26%)
    2 / 177 (1.13%)
         occurrences all number
    0
    4
    2
    Skin and subcutaneous tissue disorders
    PRURITUS
         subjects affected / exposed
    1 / 175 (0.57%)
    6 / 177 (3.39%)
    2 / 177 (1.13%)
         occurrences all number
    1
    6
    2
    Psychiatric disorders
    SLEEP DISORDER
         subjects affected / exposed
    1 / 175 (0.57%)
    3 / 177 (1.69%)
    4 / 177 (2.26%)
         occurrences all number
    1
    3
    4
    INSOMNIA
         subjects affected / exposed
    4 / 175 (2.29%)
    7 / 177 (3.95%)
    5 / 177 (2.82%)
         occurrences all number
    4
    8
    5
    DEPRESSION
         subjects affected / exposed
    4 / 175 (2.29%)
    4 / 177 (2.26%)
    2 / 177 (1.13%)
         occurrences all number
    4
    4
    2
    ANXIETY
         subjects affected / exposed
    5 / 175 (2.86%)
    9 / 177 (5.08%)
    10 / 177 (5.65%)
         occurrences all number
    5
    10
    11
    ABNORMAL DREAMS
         subjects affected / exposed
    1 / 175 (0.57%)
    6 / 177 (3.39%)
    10 / 177 (5.65%)
         occurrences all number
    1
    6
    10
    HALLUCINATION, VISUAL
         subjects affected / exposed
    0 / 175 (0.00%)
    5 / 177 (2.82%)
    0 / 177 (0.00%)
         occurrences all number
    0
    5
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    5 / 175 (2.86%)
    4 / 177 (2.26%)
    4 / 177 (2.26%)
         occurrences all number
    5
    4
    5
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 175 (0.00%)
    5 / 177 (2.82%)
    6 / 177 (3.39%)
         occurrences all number
    0
    5
    7
    NECK PAIN
         subjects affected / exposed
    3 / 175 (1.71%)
    4 / 177 (2.26%)
    4 / 177 (2.26%)
         occurrences all number
    4
    4
    4
    MUSCLE SPASMS
         subjects affected / exposed
    1 / 175 (0.57%)
    3 / 177 (1.69%)
    4 / 177 (2.26%)
         occurrences all number
    1
    3
    4
    BACK PAIN
         subjects affected / exposed
    6 / 175 (3.43%)
    4 / 177 (2.26%)
    7 / 177 (3.95%)
         occurrences all number
    6
    4
    8
    Infections and infestations
    URINARY TRACT INFECTION
         subjects affected / exposed
    9 / 175 (5.14%)
    3 / 177 (1.69%)
    6 / 177 (3.39%)
         occurrences all number
    10
    4
    7
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 175 (1.71%)
    4 / 177 (2.26%)
    0 / 177 (0.00%)
         occurrences all number
    3
    4
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    4 / 175 (2.29%)
    6 / 177 (3.39%)
    2 / 177 (1.13%)
         occurrences all number
    5
    6
    2
    COVID-19
         subjects affected / exposed
    4 / 175 (2.29%)
    6 / 177 (3.39%)
    9 / 177 (5.08%)
         occurrences all number
    4
    6
    9
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    1 / 175 (0.57%)
    5 / 177 (2.82%)
    3 / 177 (1.69%)
         occurrences all number
    1
    5
    3

    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
    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
    Correct errors and to harmonize similar content across the Phase 3 tavapadon protocols via modification and clarification of eligibility criteria, procedural aspects, and statistical considerations.
    06 Jul 2023
    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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