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    Clinical Trial Results:
    A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)

    Summary
    EudraCT number
    		 2017-000135-14
    Trial protocol
    		 AT   DE   GB   ES   IT  
    Global end of trial date
    02 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2021
    First version publication date
    26 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PXT-CL17-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03162874
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 H.Lundbeck A/S: 18023A
    Sponsors
    Sponsor organisation name
    Prexton Therapeutics BV
    Sponsor organisation address
    Kloosterstraat 9, Oss, Netherlands, 5349 AB
    Public contact
    Lundbeck Clinical Trials, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    Lundbeck Clinical Trials, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.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
    02 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess the efficacy of 2 doses of foliglurax as an adjunct to levodopa in the reduction of OFF time in participants with Parkinson’s Disease (PD).
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki (2013) and International Council for Harmonisation (ICH) Good Clinical Practice (1996).
    Background therapy
    		 Participants continued to take their usual levodopa treatment, as well as permitted anti-Parkinsonian drugs (if any), from their own prescribed supply throughout the study. Participants were treated with a stable regimen of their levodopa-containing therapy and any permitted anti-Parkinsonian drugs during the study according to their usual regimen.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2017
    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
    Spain: 24
    Country: Number of subjects enrolled
    United Kingdom: 26
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    France: 33
    Country: Number of subjects enrolled
    Germany: 32
    Country: Number of subjects enrolled
    Italy: 39
    Worldwide total number of subjects
    157
    EEA total number of subjects
    157
    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)
    62
    From 65 to 84 years
    95
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants who met all the inclusion criteria and none of the exclusion criteria were enrolled. Participants were randomised in 1:1:1 ratio to 3 treatment groups: Foliglurax 10 mg twice daily (BID), Foliglurax 30 mg BID, or Placebo BID.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Foliglurax 10 mg BID
    Arm description
    		 Participants received 10 milligrams (mg) foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Foliglurax
    Investigational medicinal product code
    PXT002331
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Foliglurax was administered per dose and schedule specified in the arm description.

    Arm title
    		 Foliglurax 30 mg BID
    Arm description
    		 Participants received 30 mg foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Foliglurax
    Investigational medicinal product code
    PXT002331
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Foliglurax was administered per dose and schedule specified in the arm description.

    Arm title
    		 Placebo BID
    Arm description
    		 Participants received placebo matched to foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PXT002331
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to foliglurax was administered per schedule specified in the arm description.

    Number of subjects in period 1
    		Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID
    Started
    53
    52
    52
    Received at least 1 dose of study drug
    53
    52
    52
    Completed
    45
    48
    46
    Not completed
    8
    4
    6
         Consent withdrawn by subject
    1
    2
    2
         Adverse event, non-fatal
    5
    2
    1
         Other than specified
    -
    -
    1
         Protocol deviation
    2
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Foliglurax 10 mg BID
    Reporting group description
    		 Participants received 10 milligrams (mg) foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.

    Reporting group title
    Foliglurax 30 mg BID
    Reporting group description
    		 Participants received 30 mg foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.

    Reporting group title
    Placebo BID
    Reporting group description
    		 Participants received placebo matched to foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.

    Reporting group values
    		 Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID Total
    Number of subjects
    		 53 52 52 157
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66 ± 9.2 66 ± 9.1 67 ± 8.9 -
    Gender categorical
    Units: Subjects
        Female
    		 21 28 24 73
        Male
    		 32 24 28 84

    End points

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    End points reporting groups
    Reporting group title
    Foliglurax 10 mg BID
    Reporting group description
    		 Participants received 10 milligrams (mg) foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.

    Reporting group title
    Foliglurax 30 mg BID
    Reporting group description
    		 Participants received 30 mg foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.

    Reporting group title
    Placebo BID
    Reporting group description
    		 Participants received placebo matched to foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.

    Primary: Change From Baseline in the Daily Awake OFF Time Based on Participant Hauser Diary Entries at the End of Treatment Period (Day 28)

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    End point title
    		 Change From Baseline in the Daily Awake OFF Time Based on Participant Hauser Diary Entries at the End of Treatment Period (Day 28)
    End point description
    Participants completed a 3-day Hauser diary with waking status (time OFF) every 30 minutes while awake before the Baseline and Day 28 Visits. The Hauser diary was completed by the participant during 3 consecutive days immediately preceding each scheduled site visit. An “OFF state” was defined as the time when medication was not providing benefit with respect to mobility, slowness and stiffness. OFF episodes might be heralded by nonmotor symptoms (for example, pain, anxiety) prior to the appearance of motor symptoms. Efficacy Full Analysis Set (FAS) included all participants who received at least 1 dose of foliglurax or placebo and had a valid baseline assessment and at least 1 valid postbaseline assessment (either at Day 14 or 28) of the primary efficacy variable (that is, Hauser daily awake OFF time). Here, 'n' signifies participants analysed for this endpoint at specified timepoints.
    End point type
    Primary
    End point timeframe
    Baseline, Day 28
    End point values
    		 Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID
    Number of subjects analysed
    50
    50
    49
    Units: hours
    arithmetic mean (standard deviation)
        Baseline (n = 50, 50, 49)
    5.05 ± 2.245
    4.88 ± 2.127
    4.74 ± 2.079
        Change at Day 28 (n = 45, 47, 46)
    -0.43 ± 2.028
    -0.70 ± 2.200
    -0.31 ± 1.718
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Analysis was performed using a restricted maximum likelihood-based mixed model for repeated measures (MMRM) approach. The model included terms for treatment (10 mg Foliglurax BID, 30 mg Foliglurax BID and placebo BID), day (Day 28), day-by-treatment and site as fixed factors and the baseline OFF time score and its interaction with day as covariates.
    Comparison groups
    Foliglurax 10 mg BID v Placebo BID
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2639 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square (LS) Mean Difference
    Point estimate
    -0.27
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 0.43
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.419
    Notes
    [1] - Testing was performed at a 5% 1-sided level without adjustment for multiplicity.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Analysis was performed using a restricted maximum likelihood-based MMRM approach. The model included terms for treatment (10 mg Foliglurax BID, 30 mg Foliglurax BID and placebo BID), day (Day 28), day-by-treatment and site as fixed factors and the baseline OFF time score and its interaction with day as covariates.
    Comparison groups
    Foliglurax 30 mg BID v Placebo BID
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1455 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.44
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.12
         upper limit
    		 0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.412
    Notes
    [2] - Testing was performed at a 5% 1-sided level without adjustment for multiplicity.

    Secondary: Change From Baseline in the Total Objective Score (Parts 3 and 4) for Dyskinesia Impairment and Disability Assessed by Unified Dyskinesia Rating Scale (UDysRS) at the End of Treatment Period (Day 28)

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    End point title
    		 Change From Baseline in the Total Objective Score (Parts 3 and 4) for Dyskinesia Impairment and Disability Assessed by Unified Dyskinesia Rating Scale (UDysRS) at the End of Treatment Period (Day 28)
    End point description
    UDysRS Part 3 contains 7 questions about objective evaluation of dyskinesia impairment (dyskinesia severity, anatomic distribution, and type); and Part 4 contains 4 questions regarding dyskinesia disability based on Part 3 activities. Each question was scored with respect to severity, which was rated on a scale where 0 = normal, 1 = slight, 2 = mild, 3= moderate and 4 = severe. The scores for the 2 Parts combined ranged from 0-44; with a higher score representing more severe dyskinesia. Efficacy FAS included all participants who received at least 1 dose of foliglurax or placebo and had a valid baseline assessment and at least 1 valid postbaseline assessment (either at Day 14 or 28) of the primary efficacy variable (that is, Hauser daily awake OFF time). Here, 'n' signifies participants analysed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 28
    End point values
    		 Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID
    Number of subjects analysed
    50
    50
    49
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n = 50, 50, 49)
    17.76 ± 5.049
    17.08 ± 5.010
    18.37 ± 6.870
        Change at Day 28 (n = 47, 48, 46)
    -3.06 ± 6.281
    -3.21 ± 5.608
    -3.07 ± 6.187
    No statistical analyses for this end point

    Secondary: Change From Baseline in UDysRS Score at the End of Treatment Period (Day 28)

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    End point title
    		 Change From Baseline in UDysRS Score at the End of Treatment Period (Day 28)
    End point description
    UDysRS is a tool used to assess dyskinesia in PD. Part 1 contains 11 questions about ON time dyskinesia and the impact of ON-dyskinesia on experiences of daily living. Part 2 contains 4 questions about OFF-dystonia rating. Part 3 contains 7 questions about objective evaluation of dyskinesia impairment and Part 4 contains 4 questions regarding dyskinesia disability. Each question was scored with respect to severity, which was rated on a scale where 0 = normal, 1 = slight, 2 = mild, 3= moderate and 4 = severe. UDysRS total score was obtained by summing the item scores, ranging from 0 to 104 with higher scores indicating more disability. Efficacy FAS included all participants who received at least 1 dose of foliglurax or placebo and had a valid baseline assessment and at least 1 valid postbaseline assessment (either at Day 14 or 28) of primary efficacy variable (that is, Hauser daily awake OFF time). Here, 'n' signifies participants analysed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 28
    End point values
    		 Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID
    Number of subjects analysed
    50
    50
    49
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n = 50, 50, 49)
    42.98 ± 11.996
    41.80 ± 8.683
    43.06 ± 13.204
        Change at Day 28 (n = 47, 48, 46)
    -8.32 ± 10.933
    -8.46 ± 10.433
    -7.80 ± 9.923
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a Clinically Significant Reduction in OFF Time (at Least 1 Hour as Defined by Hauser et al.) From Baseline to End of Treatment Period (Day 28) Based on Participant Hauser Diary Entries

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    End point title
    		 Percentage of Participants Achieving a Clinically Significant Reduction in OFF Time (at Least 1 Hour as Defined by Hauser et al.) From Baseline to End of Treatment Period (Day 28) Based on Participant Hauser Diary Entries
    End point description
    Participants completed a 3-day Hauser diary with waking status (time OFF) every 30 minutes while awake before the Baseline and Day 28 Visits. The Hauser diary was completed by the participant during 3 consecutive days immediately preceding each scheduled site visit. An “OFF state” was defined as the time when medication was not providing benefit with respect to mobility, slowness and stiffness. OFF episodes might be heralded by nonmotor symptoms (for example, pain, anxiety) prior to the appearance of motor symptoms. Efficacy FAS included all participants who received at least 1 dose of foliglurax or placebo and had a valid baseline assessment and at least 1 valid postbaseline assessment (either at Day 14 or 28) of the primary efficacy variable (that is, Hauser daily awake OFF time). Here, 'Number of participants analysed' signifies participants analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 28
    End point values
    		 Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID
    Number of subjects analysed
    45
    47
    46
    Units: percentage of participants
        number (not applicable)
    31.1
    44.7
    30.4
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Percentage of Daily Awake OFF Time Based on Participant Hauser Diary Entries at the End of Treatment Period (Day 28)

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    End point title
    		 Change From Baseline in the Percentage of Daily Awake OFF Time Based on Participant Hauser Diary Entries at the End of Treatment Period (Day 28)
    End point description
    Participants completed a 3-day Hauser diary with waking status (time OFF) every 30 minutes while awake before the Baseline and Day 28 Visits. The Hauser diary was completed by the participant during 3 consecutive days immediately preceding each scheduled site visit. An “OFF state” was defined as the time when medication was not providing benefit with respect to mobility, slowness and stiffness. OFF episodes might be heralded by nonmotor symptoms (for example, pain, anxiety) prior to the appearance of motor symptoms. Efficacy FAS included all participants who received at least 1 dose of foliglurax or placebo and had a valid baseline assessment and at least 1 valid postbaseline assessment (either at Day 14 or 28) of the primary efficacy variable (that is, Hauser daily awake OFF time). Here, 'n' signifies participants analysed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 28
    End point values
    		 Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID
    Number of subjects analysed
    50
    50
    49
    Units: percentage of daily awake OFF time
    arithmetic mean (standard deviation)
        Baseline (n = 50, 50, 49)
    21.04 ± 9.353
    20.33 ± 8.861
    19.77 ± 8.661
        Change at Day 28 (n = 45, 47, 46)
    -1.79 ± 8.450
    -2.90 ± 9.169
    -1.30 ± 7.158
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Daily Awake ON Time Without Troublesome Dyskinesia Based on Participant Hauser Diary Entries at the End of Treatment Period (Day 28)

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    End point title
    		 Change From Baseline in the Daily Awake ON Time Without Troublesome Dyskinesia Based on Participant Hauser Diary Entries at the End of Treatment Period (Day 28)
    End point description
    Participants completed a 3-day Hauser diary with waking status (time ON without troublesome dyskinesia) every 30 minutes while awake before the Baseline and Day 28 Visits. The Hauser diary was completed by the participant during 3 consecutive days immediately preceding each scheduled site visit. An “ON state” was defined as the time when medication was providing benefit with respect to mobility, slowness and stiffness, and might or might not be providing complete alleviation of all PD symptoms. Daily awake ON time without troublesome dyskinesia was defined as ON time without dyskinesia plus ON time with nontroublesome dyskinesia. Efficacy FAS included all participants who received at least 1 dose of foliglurax or placebo and had a valid baseline assessment and at least 1 valid postbaseline assessment (either at Day 14 or 28) of the primary efficacy variable (that is, Hauser daily awake OFF time). Here, 'n' signifies participants analysed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 28
    End point values
    		 Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID
    Number of subjects analysed
    50
    50
    49
    Units: hours
    arithmetic mean (standard deviation)
        Baseline (n = 50, 50, 49)
    8.75 ± 2.474
    8.83 ± 2.654
    8.77 ± 2.792
        Change at Day 28 (n = 45, 47, 46)
    1.05 ± 2.308
    0.95 ± 2.848
    0.56 ± 2.519
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Percentage of Daily Awake ON Time Without Troublesome Dyskinesia Based on Participant Hauser Diary Entries at the End of Treatment Period (Day 28)

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    End point title
    		 Change From Baseline in the Percentage of Daily Awake ON Time Without Troublesome Dyskinesia Based on Participant Hauser Diary Entries at the End of Treatment Period (Day 28)
    End point description
    Participants completed a 3-day Hauser diary with waking status (time ON without troublesome dyskinesia) every 30 minutes while awake before the Baseline and Day 28 Visits. The Hauser diary was completed by the participant during 3 consecutive days immediately preceding each scheduled site visit. An “ON state” was defined as the time when medication was providing benefit with respect to mobility, slowness and stiffness, and might or might not be providing complete alleviation of all PD symptoms. Daily awake ON time without troublesome dyskinesia was defined as ON time without dyskinesia plus ON time with nontroublesome dyskinesia. Efficacy FAS included all participants who received at least 1 dose of foliglurax or placebo and had a valid baseline assessment and at least 1 valid postbaseline assessment (either at Day 14 or 28) of the primary efficacy variable (that is, Hauser daily awake OFF time). Here, 'n' signifies participants analysed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 28
    End point values
    		 Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID
    Number of subjects analysed
    50
    50
    49
    Units: percentage of daily awake ON time
    arithmetic mean (standard deviation)
        Baseline (n = 50, 50, 49)
    36.46 ± 10.308
    36.79 ± 11.058
    36.55 ± 11.632
        Change at Day 28 (n = 45, 47, 46)
    4.38 ± 9.617
    3.96 ± 11.866
    2.34 ± 10.495
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose up to follow-up (up to Day 42)
    Adverse event reporting additional description
    Safety set included all eligible participants who received at least 1 dose of foliglurax or placebo.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Foliglurax 10 mg BID
    Reporting group description
    		 Participants received 10 mg foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.

    Reporting group title
    Foliglurax 30 mg BID
    Reporting group description
    		 Participants received 30 mg foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.

    Reporting group title
    Placebo BID
    Reporting group description
    		 Participants received placebo matched to foliglurax capsules orally BID on Days 1 to 27, and a final single dose on the morning of Day 28.

    Serious adverse events
    		 Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 52 (1.92%)
    3 / 52 (5.77%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Tendon injury
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 52 (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
    Nervous system disorders
    On and off phenomenon
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle rigidity
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Viral labyrinthitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 52 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Foliglurax 10 mg BID Foliglurax 30 mg BID Placebo BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 53 (22.64%)
    14 / 52 (26.92%)
    10 / 52 (19.23%)
    Investigations
    Protein urine present
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 52 (5.77%)
    1 / 52 (1.92%)
         occurrences all number
    1
    3
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 52 (5.77%)
    0 / 52 (0.00%)
         occurrences all number
    4
    3
    0
    Nervous system disorders
    Dyskinesia
         subjects affected / exposed
    3 / 53 (5.66%)
    3 / 52 (5.77%)
    4 / 52 (7.69%)
         occurrences all number
    3
    3
    4
    Headache
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 52 (3.85%)
    1 / 52 (1.92%)
         occurrences all number
    3
    2
    1
    On and off phenomenon
         subjects affected / exposed
    2 / 53 (3.77%)
    5 / 52 (9.62%)
    6 / 52 (11.54%)
         occurrences all number
    2
    5
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Oct 2018
    This amendment included the following changes: • Change in contract research organisation (CRO) medical monitor; • Clarified secondary efficacy outcome endpoints; • Clarified that there were multiple scores in the Hospital Anxiety and Depression Scale (HADS); • Moved Columbia-Suicide Severity Rating Scale (C-SSRS) and Scale for Assessment of Positive Symptoms for Parkinson's Disease Psychosis (SAPS-PD) to Safety and Tolerability Assessments; • Corrected the baseline QTcF as the average from the Screening Visit 1 and clarified that the time window for UDysRS assessments was defined during the Screening Visit 2; • Corrected exclusion criterion to include human immunodeficiency virus (HIV)-1 or -2 antibodies instead of both HIV-1 and -2 antibodies; • Added flexibility to exclusion criterion to clarify that participant rescreening was permitted, as this criterion was not intended to apply to screen failures; • Clarified that electrocardiograms (ECGs) should be performed before vital signs measurements and switched assessment text accordingly; • Clarified that follicle-stimulating hormone (FSH) testing was only to be performed at screening; • Corrected clinical laboratory units as per the central laboratory; • Updated the blood volume for foliglurax pharmacokinetic (PK) as a smaller volume could be used; • Revised the efficacy FAS and efficacy per protocol set (PPS) to better meet regulatory expectations and changed populations to sets; • Revised the primary efficacy analysis model to better meet regulatory expectations and modified the primary efficacy analyses so it was based on the efficacy FAS but was also to be repeated on the efficacy PPS; • Added a blinded interim PK analysis to support formulation development; • Clarified that serious adverse events (SAEs) were reported via electronic case report form (eCRF) and paper SAE report; • Clarified multiple items in the schedule of activities.

    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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