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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 as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)

    Summary
    EudraCT number
    		 2019-002951-40
    Trial protocol
    		 DE   CZ   ES   FR   HU   BG   IT  
    Global end of trial date
    15 Feb 2024

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CVL-751-PD-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 118,647
    Sponsors
    Sponsor organisation name
    Cerevel Therapeutics, LLC
    Sponsor organisation address
    222 Jacobs Street, Suite 200, Cambridge, United States, 02141
    Public contact
    AbbVie, Global Medical Services, +1 800-633-9110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    AbbVie, Global Medical Services, +1 800-633-9110, 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
    15 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 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 effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's Disease (PD) who are experiencing motor fluctuations.
    Protection of trial subjects
    The investigator or his/her representative explained the nature of the trial to the participant or his/her legally authorized representative and answered all questions regarding the trial. Participants were informed that their participation was voluntary. Participants were required to sign a statement of informed consent that met the requirements of 21 CFR 50, local regulations, ICH guidelines, HIPAA requirements, where applicable, and the IRB/IEC or trial center. A copy of the ICF was provided to the participant or the participant’s legally authorized representative.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Sep 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
    Australia: 27
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    Serbia: 15
    Country: Number of subjects enrolled
    Ukraine: 46
    Country: Number of subjects enrolled
    United States: 139
    Country: Number of subjects enrolled
    Poland: 104
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    Bulgaria: 39
    Country: Number of subjects enrolled
    Czechia: 24
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 49
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Italy: 22
    Worldwide total number of subjects
    507
    EEA total number of subjects
    265
    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)
    223
    From 65 to 84 years
    284
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In this Phase 3, Double-Blind study, a total of 507 subjects with Parkinson’s Disease(PD) were randomized in a 1:1 ratio to receive Tavapadon (5 mg to 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, Monitor, Data analyst
    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 were 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 SAEs or AESI to regulatory agency.

    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
    Participants will receive placebo matching to tavapadon QD orally for 27 weeks.

    Arm title
    		 Tavapadon
    Arm description
    		 Participants will be randomized to receive tavapadon 5 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
    Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.

    Number of subjects in period 1
    		Placebo Tavapadon
    Started
    255
    252
    Completed
    206
    159
    Not completed
    49
    93
         Treatment with Prohibited Concomitant Medications
    1
    -
         Consent withdrawn by subject
    12
    33
         Non- Compliance with Study Drug
    -
    2
         Physician decision
    -
    1
         Failure to Meet Continuation Criteria
    -
    1
         Adverse event, non-fatal
    23
    43
         Not specified
    2
    2
         Site Terminated by Sponsor
    3
    5
         Lost to follow-up
    3
    4
         Lack of efficacy
    5
    2

    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
    Reporting group description
    		 Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.

    Reporting group values
    		 Placebo Tavapadon Total
    Number of subjects
    		 255 252 507
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.1 ( 8.52 ) 65.6 ( 8.42 ) -
    Gender categorical
    Units: Subjects
        Female
    		 85 101 186
        Male
    		 170 151 321
    ON Time (hours) Without Troublesome Dyskinesia at Baseline
    Units: hours
        arithmetic mean (standard deviation)
    		 10.148 ( 2.637 ) 9.884 ( 2.569 ) -
    OFF Time (hours) at Baseline
    Units: hours
        arithmetic mean (standard deviation)
    		 5.408 ( 2.484 ) 5.638 ( 2.246 ) -
    MDS-UPDRS Score at Baseline (Part I)
    The MDS-UPDRS is a multidimensional scale that assesses the motor and non-motor impacts of PD across 4 parts. Each item of all the parts will be rated on a scale from 0 to 4 on which 0 = normal, 1=slight, 2=mild, 3=moderate, and 4=severe.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 7.5 ( 4.93 ) 8.0 ( 5.13 ) -
    MDS-UPDRS Score at Baseline (Part II)
    The MDS-UPDRS is a multidimensional scale that assesses the motor and non-motor impacts of PD across 4 parts. Each item of all the parts will be rated on a scale from 0 to 4 on which 0 = normal, 1=slight, 2=mild, 3=moderate, and 4=severe.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 12.5 ( 7.05 ) 13.3 ( 6.54 ) -
    MDS-UPDRS Score at Baseline (Part III)
    The MDS-UPDRS is a multidimensional scale that assesses the motor and non-motor impacts of PD across 4 parts. Each item of all the parts will be rated on a scale from 0 to 4 on which 0 = normal, 1=slight, 2=mild, 3=moderate, and 4=severe.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 32.4 ( 14.26 ) 32.6 ( 14.34 ) -

    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
    Reporting group description
    		 Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.

    Primary: Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)

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    End point title
    		 Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
    End point description
    The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total "on" time without troublesome dyskinesia will be assessed and reported at endpoint.
    End point type
    Primary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    201
    153
    Units: Hours
        least squares mean (standard error)
    0.619 ( 0.188 )
    1.721 ( 0.207 )
    Statistical analysis title
    		 Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    354
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    1.103
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.553
         upper limit
    		 1.653
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Notes
    [1] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.

    Secondary: Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)

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    End point title
    		 Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
    End point description
    The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total daily "Off" time will be assessed and reported at endpoint.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    201
    153
    Units: hours
        least squares mean (standard error)
    -0.933 ( 0.182 )
    -1.876 ( 0.200 )
    Statistical analysis title
    		 Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    354
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006 [2]
    Method
    		 Mixed-effect Model Repeated Measureme
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -0.943
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.475
         upper limit
    		 -0.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.271
    Notes
    [2] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.

    Secondary: Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)

    		 Close Top of page
    End point title
    		 Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
    End point description
    The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total "on" time without troublesome dyskinesia will be assessed and reported at different time points.
    End point type
    Secondary
    End point timeframe
    Week 2, 5, 8, 11, 14, 18, 22, and 26
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    245
    242
    Units: Hours
    least squares mean (standard error)
        Week 2
    0.535 ( 0.133 )
    0.305 ( 0.133 )
        Week 5
    0.516 ( 0.148 )
    0.616 ( 0.151 )
        Week 8
    0.470 ( 0.162 )
    1.052 ( 0.168 )
        Week 11
    0.705 ( 0.163 )
    1.063 ( 0.171 )
        Week 14
    0.584 ( 0.175 )
    1.282 ( 0.187 )
        Week 18
    0.623 ( 0.174 )
    1.592 ( 0.185 )
        Week 22
    0.870 ( 0.177 )
    1.749 ( 0.190 )
        Week 26
    0.619 ( 0.188 )
    1.721 ( 0.207 )
    Statistical analysis title
    		 Week 2: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2216 [3]
    Method
    		 Mixed-effect Model Repeated Measureme
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.139
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.188
    Notes
    [3] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 5: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6379 [4]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    0.099
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.316
         upper limit
    		 0.515
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.211
    Notes
    [4] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 8: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0132 [5]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    0.582
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.122
         upper limit
    		 1.042
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.234
    Notes
    [5] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 11: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1299 [6]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    0.358
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.106
         upper limit
    		 0.821
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.236
    Notes
    [6] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 14: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0068 [7]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    0.698
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.194
         upper limit
    		 1.202
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.257
    Notes
    [7] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 18: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002 [8]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    0.969
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.469
         upper limit
    		 1.469
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.254
    Notes
    [8] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 22: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0008 [9]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    0.879
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.369
         upper limit
    		 1.389
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.259
    Notes
    [9] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [10]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    1.103
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.553
         upper limit
    		 1.653
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Notes
    [10] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.

    Secondary: Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)

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    End point title
    		 Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
    End point description
    The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total daily "Off" time will be assessed and reported at different time points.
    End point type
    Secondary
    End point timeframe
    Week 2, 5, 8, 11, 14, 18, 22, and 26
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    245
    242
    Units: Hours
    least squares mean (standard error)
        Week 2
    -0.598 ( 0.127 )
    -0.490 ( 0.127 )
        Week 5
    -0.612 ( 0.144 )
    -0.849 ( 0.146 )
        Week 8
    -0.549 ( 0.153 )
    -1.367 ( 0.159 )
        Week 11
    -0.876 ( 0.156 )
    -1.629 ( 0.164 )
        Week 14
    -0.779 ( 0.173 )
    -1.682 ( 0.185 )
        Week 18
    -0.786 ( 0.176 )
    -1.810 ( 0.187 )
        Week 22
    -1.014 ( 0.179 )
    -1.993 ( 0.191 )
        Week 26
    -0.933 ( 0.182 )
    -1.876 ( 0.200 )
    Statistical analysis title
    		 Week 2: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5471 [11]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    0.108
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.245
         upper limit
    		 0.461
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Notes
    [11] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 5: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2488 [12]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -0.237
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 0.166
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.205
    Notes
    [12] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 8: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002 [13]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -0.818
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.252
         upper limit
    		 -0.384
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.221
    Notes
    [13] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 11: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [14]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -0.753
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.199
         upper limit
    		 -0.307
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.227
    Notes
    [14] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 14: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004 [15]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -0.904
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.403
         upper limit
    		 -0.405
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.254
    Notes
    [15] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 18: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [16]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -1.024
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.528
         upper limit
    		 -0.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.256
    Notes
    [16] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 22: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002 [17]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -0.979
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.493
         upper limit
    		 -0.465
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.261
    Notes
    [17] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Week 26: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006 [18]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -0.943
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.475
         upper limit
    		 -0.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.271
    Notes
    [18] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.

    Secondary: Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual 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 I, II and III Individual Score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Placebo Tavapadon
    Number of subjects analysed
    245
    242
    Units: units on a scale
    least squares mean (standard error)
        Part I
    0.0 ( 0.27 )
    0.4 ( 0.30 )
        Part II
    -0.1 ( 0.35 )
    -1.4 ( 0.39 )
        Part III
    -4.6 ( 0.65 )
    -7.0 ( 0.71 )
    Statistical analysis title
    		 Part I: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3265 [19]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [19] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Part II: Placebo, Tavapadon
    Comparison groups
    Placebo v Tavapadon
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0203 [20]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.52
    Notes
    [20] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.
    Statistical analysis title
    		 Part III: Placebo, Tavapadon
    Comparison groups
    Tavapadon v Placebo
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0118 [21]
    Method
    		 Mixed-effect Model Repeated Measurement
    Parameter type
    		 LS Mean of Difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 -0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.96
    Notes
    [21] - LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.

    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 and 189 days for Placebo and Tavapadon, 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; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    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
    Reporting group description
    		 Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.

    Serious adverse events
    		 Placebo Tavapadon
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 254 (5.51%)
    17 / 251 (6.77%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Investigations
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-CELL SMALL LYMPHOCYTIC LYMPHOMA
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATIC CARCINOMA METASTATIC
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Injury, poisoning and procedural complications
    LYME DISEASE
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (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
    0 / 254 (0.00%)
    3 / 251 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIP FRACTURE
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JOINT DISLOCATION
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THERMAL BURN
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ANGINA PECTORIS
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE CHRONIC
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    COLLOID BRAIN CYST
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIZZINESS
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MIDDLE CEREBRAL ARTERY STROKE
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ON AND OFF PHENOMENON
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBARACHNOID HAEMORRHAGE
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    GLAUCOMA
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 254 (0.00%)
    2 / 251 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIATUS HERNIA
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    ANXIETY DISORDER
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HALLUCINATION, VISUAL
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUICIDAL IDEATION
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    INTERVERTEBRAL DISC DISORDER
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RHEUMATIC DISORDER
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    BRONCHITIS BACTERIAL
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 254 (0.79%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 PNEUMONIA
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EYE INFECTION
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTIVE ANEURYSM
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBACUTE ENDOCARDITIS
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Tavapadon
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    90 / 254 (35.43%)
    130 / 251 (51.79%)
    Investigations
    WEIGHT DECREASED
         subjects affected / exposed
    1 / 254 (0.39%)
    7 / 251 (2.79%)
         occurrences all number
    1
    7
    Injury, poisoning and procedural complications
    CONTUSION
         subjects affected / exposed
    6 / 254 (2.36%)
    4 / 251 (1.59%)
         occurrences all number
    7
    4
    FALL
         subjects affected / exposed
    13 / 254 (5.12%)
    13 / 251 (5.18%)
         occurrences all number
    20
    18
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    1 / 254 (0.39%)
    9 / 251 (3.59%)
         occurrences all number
    1
    9
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    3 / 254 (1.18%)
    15 / 251 (5.98%)
         occurrences all number
    3
    15
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    8 / 254 (3.15%)
    18 / 251 (7.17%)
         occurrences all number
    8
    20
    DYSGEUSIA
         subjects affected / exposed
    0 / 254 (0.00%)
    7 / 251 (2.79%)
         occurrences all number
    0
    7
    DYSKINESIA
         subjects affected / exposed
    4 / 254 (1.57%)
    25 / 251 (9.96%)
         occurrences all number
    7
    32
    DYSTONIA
         subjects affected / exposed
    0 / 254 (0.00%)
    7 / 251 (2.79%)
         occurrences all number
    0
    9
    HEADACHE
         subjects affected / exposed
    7 / 254 (2.76%)
    17 / 251 (6.77%)
         occurrences all number
    7
    23
    SOMNOLENCE
         subjects affected / exposed
    11 / 254 (4.33%)
    13 / 251 (5.18%)
         occurrences all number
    11
    13
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    0 / 254 (0.00%)
    8 / 251 (3.19%)
         occurrences all number
    0
    8
    FATIGUE
         subjects affected / exposed
    11 / 254 (4.33%)
    10 / 251 (3.98%)
         occurrences all number
    11
    10
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    1 / 254 (0.39%)
    6 / 251 (2.39%)
         occurrences all number
    1
    6
    CONSTIPATION
         subjects affected / exposed
    8 / 254 (3.15%)
    10 / 251 (3.98%)
         occurrences all number
    9
    10
    DRY MOUTH
         subjects affected / exposed
    2 / 254 (0.79%)
    7 / 251 (2.79%)
         occurrences all number
    2
    7
    NAUSEA
         subjects affected / exposed
    11 / 254 (4.33%)
    36 / 251 (14.34%)
         occurrences all number
    14
    44
    Skin and subcutaneous tissue disorders
    HYPERHIDROSIS
         subjects affected / exposed
    6 / 254 (2.36%)
    3 / 251 (1.20%)
         occurrences all number
    6
    3
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    7 / 254 (2.76%)
    8 / 251 (3.19%)
         occurrences all number
    7
    8
    DEPRESSION
         subjects affected / exposed
    2 / 254 (0.79%)
    6 / 251 (2.39%)
         occurrences all number
    2
    7
    HALLUCINATION, VISUAL
         subjects affected / exposed
    3 / 254 (1.18%)
    13 / 251 (5.18%)
         occurrences all number
    3
    14
    INSOMNIA
         subjects affected / exposed
    7 / 254 (2.76%)
    1 / 251 (0.40%)
         occurrences all number
    7
    1
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    7 / 254 (2.76%)
    5 / 251 (1.99%)
         occurrences all number
    7
    5
    Infections and infestations
    COVID-19
         subjects affected / exposed
    7 / 254 (2.76%)
    13 / 251 (5.18%)
         occurrences all number
    7
    13
    NASOPHARYNGITIS
         subjects affected / exposed
    6 / 254 (2.36%)
    7 / 251 (2.79%)
         occurrences all number
    6
    7
    URINARY TRACT INFECTION
         subjects affected / exposed
    7 / 254 (2.76%)
    7 / 251 (2.79%)
         occurrences all number
    9
    10
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    1 / 254 (0.39%)
    6 / 251 (2.39%)
         occurrences all number
    1
    6

    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
    03 Sep 2021
    Version 3.0
    06 Jul 2023
    Version 4.0

    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
    For support, Contact us.
    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
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