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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled phase IIB study evaluating the efficacy of mesdopetam on daily on-time without troublesome dyskinesia in patients with Parkinson’s disease

    Summary
    EudraCT number
    		 2020-002010-41
    Trial protocol
    		 FR   IT  
    Global end of trial date
    30 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2024
    First version publication date
    31 Jan 2024
    Other versions
    Summary report(s)
    		 Poster_Study results

    Trial information

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    Trial identification
    Sponsor protocol code
    IRL790C005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04435431
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Integrative Research Laboratories Sweden AB (IRLAB)
    Sponsor organisation address
    Arvid Wallgrens Backe 20, Göteborg, Sweden, SE-413 46
    Public contact
    Joakim Tedroff, Integrative Research Laboratories Sweden AB (IRLAB), +46 (0)707 601 16 91, joakim.tedroff@irlab.se
    Scientific contact
    Joakim Tedroff, Integrative Research Laboratories Sweden AB (IRLAB), +46 (0)707 601 16 91, joakim.tedroff@irlab.se
    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
    25 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Dec 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To evaluate the effectiveness of adjunctive treatment with mesdopetam dosed at 2.5 mg, 5 mg or 7.5 mg b.i.d. (permitting a single 2.5 mg dose reduction to a minimum dose of 2.5 mg, up to Day 28) compared to placebo in patients with PD exhibiting troublesome ON-phase dyskinesia.
    Protection of trial subjects
    This study was conducted in compliance with the International Conference on Harmonization Good Clinical Practice (ICH GCP) Guideline for good clinical practice E6(R2) and with the ethical principles originating in the Declaration of Helsinki. Written informed consent was obtained from all study subjects before any study related procedures were performed.
    Background therapy
    		 Patients included in the study had to be on a stable regimen of antiparkinson medications for at least 30 days prior to first home diary completion, which must include a levodopa preparation administered 3-8 times/day (excluding nighttime levodopa) and willing to continue the same doses and regimens during study participation. Rescue medications such as Madopar dispersable and Apomorphine injections were allowed if prescribed PRN prior to study entry.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 62
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    Serbia: 15
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    United States: 36
    Worldwide total number of subjects
    155
    EEA total number of subjects
    97
    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)
    65
    From 65 to 84 years
    90
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment period was 22.5 months (29 Oct 2020 - 12 Sep 2022). 156 subjects were randomized to mesdopetam 2.5 mg (40 subj), 5.0 mg (38 subj) or 7.5 mg (39 subj) or to placebo (39 subj). 125 subjects completed the study: 2.5 mg (32 subj), 5.0 mg (31 subj), 7.5 mg (29 subj), placebo (33 subj).

    Pre-assignment
    Screening details
    		 The screening period was up to 8 weeks before start of Investigational Medicinal Product (IMP) administration. At the screening visit consenting patients were screened for eligibility according to study specific inclusion/exclusion criteria. 192 subjects were screened of which 156 were randomized.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mesdopetam 2.5 mg
    Arm description
    		 Mesdopetam (IRL790) 2.5 mg hard capsule. Oral administration b.i.d.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mesdopetam
    Investigational medicinal product code
    IRL790
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    IMP was given twice daily (b.i.d.) during 84 consecutive days. The starting dose was 5 mg b.i.d. (mesdopetam or placebo) during the dose run-in period (one week) and thereafter mesdopetam 2.5 mg, 5 mg or 7.5 mg or placebo b.i.d as randomized. If a patient experienced increased parkinsonism and/or consistent increase in motor OFF time, during the treatment period from Visit 2 up to Visit 3 (i.e. Day 9 – Day 28 ±4 days), the dosing could be reduced by 2,5 mg b.i.d. A dose reduction was allowed at only one occasion, where after the dosing should be kept stable until the EOT visit (Day 84). The capsules were swallowed together with 200 mL of water in the morning and in the afternoon approximately 8 hours apart on each administration day. Formulation details: 2.5 mg free base equivalent: White hard Hydroxypropyl Methylcellulose (HPMC) capsule, coni snap size 3, colour white containing mesdopetam x ½ L-tartrate.

    Arm title
    		 Mesdopetam 5 mg
    Arm description
    		 Mesdopetam (IRL790) 5 mg hard capsule. Oral administration b.i.d.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mesdopetam
    Investigational medicinal product code
    IRL790
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    IMP was given twice daily (b.i.d.) during 84 consecutive days. The starting dose was 5 mg b.i.d. (mesdopetam or placebo) during the dose run-in period (one week) and thereafter mesdopetam 2.5 mg, 5 mg or 7.5 mg or placebo b.i.d as randomized. If a patient experienced increased parkinsonism and/or consistent increase in motor OFF time, during the treatment period from Visit 2 up to Visit 3 (i.e. Day 9 – Day 28 ±4 days), the dosing could be reduced by 2,5 mg b.i.d. A dose reduction was allowed at only one occasion, where after the dosing should be kept stable until the EOT visit (Day 84). The capsules were swallowed together with 200 mL of water in the morning and in the afternoon approximately 8 hours apart on each administration day. Formulation details: 5 mg free base equivalent: White hard Hydroxypropyl Methylcellulose (HPMC) capsule, coni snap size 3, colour white containing mesdopetam x ½ L-tartrate.

    Arm title
    		 Mesdopetam 7.5 mg
    Arm description
    		 Mesdopetam (IRL790) 7.5 mg hard capsule. Oral administration b.i.d.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mesdopetam
    Investigational medicinal product code
    IRL790
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Other use
    Dosage and administration details
    IMP was given twice daily (b.i.d.) during 84 consecutive days. The starting dose was 5 mg b.i.d. (mesdopetam or placebo) during the dose run-in period (one week) and thereafter mesdopetam 2.5 mg, 5 mg or 7.5 mg or placebo b.i.d as randomized. If a patient experienced increased parkinsonism and/or consistent increase in motor OFF time, during the treatment period from Visit 2 up to Visit 3 (i.e. Day 9 – Day 28 ±4 days), the dosing could be reduced by 2,5 mg b.i.d. A dose reduction was allowed at only one occasion, where after the dosing should be kept stable until the EOT visit (Day 84). The capsules were swallowed together with 200 mL of water in the morning and in the afternoon approximately 8 hours apart on each administration day. Formulation details: 7.5 mg free base equivalent: White hard Hydroxypropyl Methylcellulose (HPMC) capsule, coni snap size 3, colour white containing mesdopetam x ½ L-tartrate.

    Arm title
    		 Placebo
    Arm description
    		 Placebo comparator. Matching placebo hard capsule. Oral administration b.i.d.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    IMP was given twice daily (b.i.d.) during 84 consecutive days. The starting dose was 5 mg b.i.d. (mesdopetam or placebo) during the dose run-in period (one week) and thereafter mesdopetam 2.5 mg, 5 mg or 7.5 mg or placebo b.i.d as randomized. If a patient experienced increased parkinsonism and/or consistent increase in motor OFF time, during the treatment period from Visit 2 up to Visit 3 (i.e. Day 9 – Day 28 ±4 days), the dosing could be reduced by 2,5 mg b.i.d. A dose reduction was allowed at only one occasion, where after the dosing should be kept stable until the EOT visit (Day 84). The capsules were swallowed together with 200 mL of water in the morning and in the afternoon approximately 8 hours apart on each administration day. Formulation details: White hard HPMC capsule, coni snap size 3, colour white containing starch. Capsules are identical in appearance to active IMP.

    Number of subjects in period 1
    		Mesdopetam 2.5 mg Mesdopetam 5 mg Mesdopetam 7.5 mg Placebo
    Started
    40
    38
    38
    39
    Completed
    32
    31
    29
    33
    Not completed
    8
    7
    9
    6
         Adverse event, serious fatal
    1
    -
    1
    -
         Physician decision
    1
    -
    -
    -
         Consent withdrawn by subject
    1
    4
    3
    2
         Adverse event, non-fatal
    4
    3
    2
    4
         Non-compliance with study drug
    -
    -
    2
    -
         Protocol deviation
    1
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mesdopetam 2.5 mg
    Reporting group description
    		 Mesdopetam (IRL790) 2.5 mg hard capsule. Oral administration b.i.d.

    Reporting group title
    Mesdopetam 5 mg
    Reporting group description
    		 Mesdopetam (IRL790) 5 mg hard capsule. Oral administration b.i.d.

    Reporting group title
    Mesdopetam 7.5 mg
    Reporting group description
    		 Mesdopetam (IRL790) 7.5 mg hard capsule. Oral administration b.i.d.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator. Matching placebo hard capsule. Oral administration b.i.d.

    Reporting group values
    		 Mesdopetam 2.5 mg Mesdopetam 5 mg Mesdopetam 7.5 mg Placebo Total
    Number of subjects
    		 40 38 38 39 155
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 17 15 17 16 65
        From 65-84 years
    		 23 23 21 23 90
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.0 ( 9.3 ) 64.9 ( 9.6 ) 65.0 ( 10.2 ) 64.5 ( 8.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 17 17 25 73
        Male
    		 26 21 21 14 82
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 2 5 6 15
        Not Hispanic or Latino
    		 38 36 33 33 140
    Race
    Units: Subjects
        White
    		 40 35 36 39 150
        Black or African American
    		 1 2 3
        Asian
    		 1 1
        Unknown
    		 1 1
    Height at Screening
    Units: cm
        arithmetic mean (standard deviation)
    		 167.8 ( 7.6 ) 167.0 ( 8.8 ) 167.8 ( 8.5 ) 165.7 ( 9.3 ) -
    Weight at Screening
    Units: kg
        arithmetic mean (standard deviation)
    		 76.9 ( 15.0 ) 73.1 ( 14.8 ) 73.1 ( 13.7 ) 70.3 ( 17.3 ) -
    BMI at Screening
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.1 ( 4.3 ) 26.1 ( 4.6 ) 26.0 ( 5.0 ) 25.6 ( 6.1 ) -
    Subject analysis sets

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Safety Analysis Set (SAS) includes all randomized patients who received at least 1 dose of IMP.

    Subject analysis sets values
    		 Safety Analysis Set
    Number of subjects
    155
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    65
        From 65-84 years
    90
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.9 ( 9.3 )
    Gender categorical
    Units: Subjects
        Female
    73
        Male
    82
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    15
        Not Hispanic or Latino
    140
    Race
    Units: Subjects
        White
    150
        Black or African American
    3
        Asian
    1
        Unknown
    1
    Height at Screening
    Units: cm
        arithmetic mean (standard deviation)
    167.1 ( 8.5 )
    Weight at Screening
    Units: kg
        arithmetic mean (standard deviation)
    73.4 ( 15.3 )
    BMI at Screening
    Units: kg/m2
        arithmetic mean (standard deviation)
    26.2 ( 5.0 )

    End points

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    End points reporting groups
    Reporting group title
    Mesdopetam 2.5 mg
    Reporting group description
    		 Mesdopetam (IRL790) 2.5 mg hard capsule. Oral administration b.i.d.

    Reporting group title
    Mesdopetam 5 mg
    Reporting group description
    		 Mesdopetam (IRL790) 5 mg hard capsule. Oral administration b.i.d.

    Reporting group title
    Mesdopetam 7.5 mg
    Reporting group description
    		 Mesdopetam (IRL790) 7.5 mg hard capsule. Oral administration b.i.d.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator. Matching placebo hard capsule. Oral administration b.i.d.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Safety Analysis Set (SAS) includes all randomized patients who received at least 1 dose of IMP.

    Primary: Change in average daily hours of ON-time without troublesome dyskinesia with mesdopetam compared to placebo as assessed with 24-hour patient home diaries from baseline to end of treatment (EOT) (Visit 5, Week 12).

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    End point title
    		 Change in average daily hours of ON-time without troublesome dyskinesia with mesdopetam compared to placebo as assessed with 24-hour patient home diaries from baseline to end of treatment (EOT) (Visit 5, Week 12).
    End point description
    Patients recorded their 24-hours motor function in 30-minute intervals, beginning at midnight. For each 30-minute interval the patient rated the state he or she had been in for the past 30 minutes; OFF, ON (without troublesome dyskinesia), ON with troublesome dyskinesia or Asleep. Improvement in total daily hours of ON-time without troublesome dyskinesia is defined as an increase in the daily hours spent in this motor state.
    End point type
    Primary
    End point timeframe
    The change from baseline to end of treatment (EOT) (Visit 5, Week 12).
    End point values
    		 Mesdopetam 2.5 mg Mesdopetam 5 mg Mesdopetam 7.5 mg Placebo
    Number of subjects analysed
    35 [1]
    35 [2]
    33 [3]
    37 [4]
    Units: Total daily hours
    1211
    1737
    2233
    1985
    Notes
    [1] - Full Analysis Set
    [2] - Full Analysis Set
    [3] - Full Analysis Set
    [4] - Full Analysis Set
    Statistical analysis title
    		 Primary endpoint
    Statistical analysis description
    Change in average daily hours of ON-time without troublesome dyskinesia with mesdopetam compared to placebo as assessed with 24-hour patient home diaries from baseline to end of treatment (EOT) (Visit 5, Week 12).
    Comparison groups
    Mesdopetam 7.5 mg v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.73
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.248
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.163
         upper limit
    		 1.659
    Variability estimate
    Standard error of the mean

    Secondary: Change from Baseline with mesdopetam compared to placebo in ON-phase dyskinesia assessed with the sum score of the modified UDysRS (parts 1, 3 and 4)

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    End point title
    		 Change from Baseline with mesdopetam compared to placebo in ON-phase dyskinesia assessed with the sum score of the modified UDysRS (parts 1, 3 and 4)
    End point description
    End point type
    Secondary
    End point timeframe
    The change from baseline to end of treatment (EOT) (Visit 5, Week 12).
    End point values
    		 Mesdopetam 2.5 mg Mesdopetam 5 mg Mesdopetam 7.5 mg Placebo
    Number of subjects analysed
    35
    35
    33
    37
    Units: Sum score
    115
    93
    120
    58
    Statistical analysis title
    		 UDysRS
    Comparison groups
    Placebo v Mesdopetam 7.5 mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.026
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.6
         upper limit
    		 -0.8
    Variability estimate
    Standard error of the mean

    Secondary: Change from Baseline with mesdopetam compared to placebo in average daily OFF-time.

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    End point title
    		 Change from Baseline with mesdopetam compared to placebo in average daily OFF-time.
    End point description
    Patients recorded their 24-hours motor function in 30-minute intervals, beginning at midnight. For each 30-minute interval the patient rated the state he or she had been in for the past 30 minutes; OFF, ON (without troublesome dyskinesia), ON with troublesome dyskinesia or Asleep.
    End point type
    Secondary
    End point timeframe
    The change from baseline to end of treatment (EOT) (Visit 5, Week 12).
    End point values
    		 Mesdopetam 2.5 mg Mesdopetam 5 mg Mesdopetam 7.5 mg Placebo
    Number of subjects analysed
    35
    35
    33
    37
    Units: Total daily hours
    29
    324
    768
    69
    Statistical analysis title
    		 OFF time
    Comparison groups
    Mesdopetam 7.5 mg v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.165
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Mesdopetam 2.5 mg
    Reporting group description
    		 Mesdopetam (IRL790) 2.5 mg hard capsule. Oral administration b.i.d.

    Reporting group title
    Mesdopetam 5 mg
    Reporting group description
    		 Mesdopetam (IRL790) 5 mg hard capsule. Oral administration b.i.d.

    Reporting group title
    Mesdopetam 7.5 mg
    Reporting group description
    		 Mesdopetam (IRL790) hard capsule 7.5 mg. Oral administration b.i.d.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator. Matching placebo hard capsule. Oral administration b.i.d.

    Serious adverse events
    		 Mesdopetam 2.5 mg Mesdopetam 5 mg Mesdopetam 7.5 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 38 (2.63%)
    2 / 38 (5.26%)
    3 / 39 (7.69%)
         number of deaths (all causes)
    1
    0
    1
    0
         number of deaths resulting from adverse events
    1
    0
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive emergency
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Parkinsonism
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Mesdopetam 2.5 mg Mesdopetam 5 mg Mesdopetam 7.5 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 40 (22.50%)
    8 / 38 (21.05%)
    6 / 38 (15.79%)
    9 / 39 (23.08%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 38 (2.63%)
    2 / 38 (5.26%)
    2 / 39 (5.13%)
         occurrences all number
    5
    1
    2
    2
    Nervous system disorders
    Parkinsonism
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 38 (5.26%)
    1 / 38 (2.63%)
    4 / 39 (10.26%)
         occurrences all number
    2
    2
    2
    4
    Dyskinesia
         subjects affected / exposed
    4 / 40 (10.00%)
    1 / 38 (2.63%)
    1 / 38 (2.63%)
    3 / 39 (7.69%)
         occurrences all number
    4
    1
    1
    4
    Musculoskeletal and connective tissue disorders
    Mobility decreased
         subjects affected / exposed
    2 / 40 (5.00%)
    4 / 38 (10.53%)
    2 / 38 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    3
    5
    5
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2021
    - Added U-hCG test at visit 3 and visit 4. - Clarifying details added to exclusion criterion 11. - Added definition of woman of childbearing potential and/or postmenopausal woman according to CTFG Guideline Recommendations related to contraception and pregnancy testing in clinical trials, Version 1.1, dated 21/09/2020. - Addition of safety parameters (vital signs, haematology/clinical chemistry incl prolactin, dipstick urinalysis and ECG) at Visit 1 (Baseline) if 29 days or more between the Screening visit and Visit 1 (Baseline). - Clarification that the three 24-hour home diaries can be completed during three consecutive days or any combination of days during the week prior V1, V3, V4 and V5. - Correction of Stage 2 Hoehn and Yahr description. - Revision of approximate number of sites participating in the study (increased from 28 to 35).

    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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