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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multi-centre phase IIa study evaluating the safety and tolerability of IRL752 in patients with Parkinson’s Disease Dementia.

    Summary
    EudraCT number
    		 2017-001673-17
    Trial protocol
    		 SE   FI  
    Global end of trial date
    25 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jun 2019
    First version publication date
    14 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IRL752C002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Integrative Research Laboratories AB
    Sponsor organisation address
    Arvid Wallgrens Backe 20, Göteborg, Sweden, SE-413 46
    Public contact
    Joakim Tedroff, Integrative Research Laboratories AB, 0046 707 60 16 91, joakim.tedroff@irlab.se
    Scientific contact
    Joakim Tedroff, Integrative Research Laboratories AB, 0046 707 60 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 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of IRL752 after repeated dosing in patients with Parkinson’s Disease Dementia (PDD).
    Protection of trial subjects
    The ICF included information that data would be recorded, collected and processed and could be transferred to European Economic Area (EEA) or non-EEA countries. In accordance with the EU Data Protection Directive (95/46/EC), the data would not identify any patients taking part in the study. The potential study patient (and/or LAR, as applicable) and his/her caregiver were informed that by signing the ICF he/she/they approved that authorized representatives from Sponsor and CTC Clinical Trial Consultant AB (CTC), the concerned IEC and CA had direct access to his/her medical records for verification of clinical study procedures. An authorization from the hospital for access to medical records by the Monitor was available, as required by local legislation. The patient had the right to request access to his/her personal data for rectification of any data that was not correct and/or complete. The Investigator filed a Patient Identification List, which included sufficient information to link records, i.e. the eCRF and clinical records. This list will be preserved for possible future inspections/audits but has not been made available to the Sponsor except for monitoring or auditing purposes.
    Background therapy
    		 Patients included in the study had to be on stable anti-Parkinson treatment for at least 30 days prior to inclusion and during the study. Treatment with Selegiline was not allowed. Concomitant treatment with pro-cognitive treatments such as Ach esterase inhibitors and Memantine were allowed.
    Evidence for comparator
    		 N/A (placebo)
    Actual start date of recruitment
    20 Sep 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
    Sweden: 31
    Country: Number of subjects enrolled
    Finland: 1
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    1
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the out-patient population at the study sites. Potentially eligible patients interested in taking part of the study could also be referred from other clinics.

    Pre-assignment
    Screening details
    		 Patients were screened (Visit 1; Screening Visit) for eligibility according to study-specific inclusion/exclusion criteria within 7-21 days before start of Investigational Medicinal Product administration.

    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
    		 Subject, Investigator, Monitor
    Blinding implementation details
    This was a double-blind study and the allocation of treatments was not disclosed until clean file had been declared and the database had been locked. Capsules of IRL752 and placebo were of identical appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IRL752
    Arm description
    		 25 subjects were treated with IRL752 (50 mg hard HPMC capsules).
    Arm type
    		 Experimental

    Investigational medicinal product name
    IRL752 50mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    IRL752 capsules, 50 mg: White hard hydroxypropylmethyl cellulose (HPMC) capsule for oral administration coni snap size 3. The starting dose of IMP was 100 mg TID. Dose adjustments could be made during the first 14 days, at the discretion of the treating physician, according to the following: - Visit 3 (Day 4): the dose could be increased to 150 mg TID, maintained at 100 mg TID, or reduced to 50 mg TID. - Visit 4 (Day 8): the dose could be increased up to 200 mg TID, maintained or reduced to any previous dose level. - Visit 5 (Day 11): the dose could be increased up to 250 mg TID, maintained or reduced to any previous dose level. The minimum dose was 50 mg (1 capsule) TID and the maximum dose was 250 mg (5 capsules) TID. The fixed IRL752 dose level for the remaining 14 days of treatment was determined on Day 14 (Visit 6) for each patient (50-250 mg TID).

    Arm title
    		 Placebo
    Arm description
    		 7 subjects were treated with placebo (hard HPMC capsules identical in appearance to IRL752 capsules).
    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
    White hard HPMC capsule for oral administration coni snap size 3 with a matching total weight as for the IRL752 50 mg capsules. The starting dose of IMP was 100 mg TID. Dose adjustments could be made during the first 14 days, at the discretion of the treating physician, according to the following: - Visit 3 (Day 4): the dose could be increased to 150 mg TID, maintained at 100 mg TID, or reduced to 50 mg TID. - Visit 4 (Day 8): the dose could be increased up to 200 mg TID, maintained or reduced to any previous dose level. - Visit 5 (Day 11): the dose could be increased up to 250 mg TID, maintained or reduced to any previous dose level. The minimum dose was 50 mg (1 capsule) TID and the maximum dose was 250 mg (5 capsules) TID. The fixed IRL752 dose level for the remaining 14 days of treatment was determined on Day 14 (Visit 6) for each patient (50-250 mg TID).

    Number of subjects in period 1
    		IRL752 Placebo
    Started
    25
    7
    Completed
    23
    6
    Not completed
    2
    1
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IRL752
    Reporting group description
    		 25 subjects were treated with IRL752 (50 mg hard HPMC capsules).

    Reporting group title
    Placebo
    Reporting group description
    		 7 subjects were treated with placebo (hard HPMC capsules identical in appearance to IRL752 capsules).

    Reporting group values
    		 IRL752 Placebo Total
    Number of subjects
    		 25 7 32
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 1 0 1
        From 65-84 years
    		 24 7 31
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.8 ± 3.89 72.7 ± 5.59 -
    Gender categorical
    Units: Subjects
        Female
    		 2 2 4
        Male
    		 23 5 28
    Race
    Units: Subjects
        White
    		 25 7 32

    End points

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    End points reporting groups
    Reporting group title
    IRL752
    Reporting group description
    		 25 subjects were treated with IRL752 (50 mg hard HPMC capsules).

    Reporting group title
    Placebo
    Reporting group description
    		 7 subjects were treated with placebo (hard HPMC capsules identical in appearance to IRL752 capsules).

    Primary: Adverse Events

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    End point title
    		 Adverse Events [1]
    End point description
    Adverse Events were spontaneously reported by the patients, observed or elicited based on non-leading questions by the Investigator or medical personnel.
    End point type
    Primary
    End point timeframe
    From signing the ICF (V1; Screening) until the follow-up assessment (V9; Follow-up). AEs occurring after first administration of IMP (TEAEs) are presented below.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    25 [2]
    7
    Units: Number of AEs
        Titration
    32
    1
        Steady state
    24
    3
    Notes
    [2] - Titration: N=25 Steady state: N=23
    No statistical analyses for this end point

    Primary: Physical examination

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    End point title
    		 Physical examination [3]
    End point description
    Physical examination findings were categorized as Normal, Abnormal not clinically significant (NCS), and Abnormal clinically significant (CS). One abnormal finding (pneumonia) assessed as clinically significant but not related to study treatment was reported for patient #1022 on Visit 8 (Day 29). The event was reported as an AE. No other clinically significant findings were reported.
    End point type
    Primary
    End point timeframe
    From Visit 1 (Screening) to Visit 9 (Follow-up).
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    25
    7
    Units: No of clinical significant (CS) values
        Abdomen (liver and spleen) - Abnormal CS
    0
    0
        Cardiovascular - Abnormal CS
    0
    0
        Ears - Abnormal CS
    0
    0
        Extremities - Abnormal CS
    0
    0
        Eyes - Abnormal CS
    0
    0
        Head - Abnormal CS
    0
    0
        Lungs - Abnormal CS
    1
    0
        Lymph nodes - Abnormal CS
    0
    0
        Neurological - Abnormal CS
    0
    0
        Nose - Abnormal CS
    0
    0
        Skin - Abnormal CS
    0
    0
        Throat - Abnormal CS
    0
    0
        Thyroid - Abnormal CS
    0
    0
    No statistical analyses for this end point

    Primary: ECG

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    End point title
    		 ECG [4]
    End point description
    Single 12-lead ECGs were recorded in supine position after 5 min of rest. The parameters PQ, QRS, QT, and QTcF intervals were recorded. There were no clinically relevant mean changes over time with regards to any of the ECG parameters evaluated and no individual abnormal values assessed as clinically significant.
    End point type
    Primary
    End point timeframe
    From Visit 1 (Screening) to Visit 8 (Follow-up).
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    25
    7
    Units: No of clinically significant (CS) values
        Visit 1, Screening - Abnormal CS
    0
    0
        Visit 6, Day 14 - Abnormal CS
    0
    0
        Visit 7, Day 28 - Abnormal CS
    0
    0
        Visit 9, Follow-up - Abnormal CS
    0
    0
    No statistical analyses for this end point

    Primary: Vital signs - Systolic blood pressure

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    End point title
    		 Vital signs - Systolic blood pressure [5]
    End point description
    Systolic/diastolic blood pressure and pulse were measured in the supine position after 5 min of rest. There were no clinically relevant mean changes over time with regards to any of the vital signs parameters evaluated and no individual abnormal values assessed as clinically significant.
    End point type
    Primary
    End point timeframe
    From Visit 1 (Screening) to Visit 8 (Follow-up).
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    25 [6]
    7 [7]
    Units: mmHg
    arithmetic mean (standard deviation)
        Visit 1, Screening
    134.5 ± 19.5
    119.6 ± 13.6
        Visit 6, Day 14
    131.4 ± 17.6
    124.0 ± 15.1
        Visit 8, Day 29
    132.9 ± 23.7
    112.0 ± 8.6
        Visit 9, Follow-up
    137.1 ± 22.3
    125.5 ± 25.0
    Notes
    [6] - Screening: N=25 Visit 6: N=23 Visit 8: N=23 Visit 9: N=24
    [7] - Screening: N=7 Visit 6: N=7 Visit 8: N=6 Visit 9: N=6
    No statistical analyses for this end point

    Primary: Safety laboratory measurements

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    End point title
    		 Safety laboratory measurements [8]
    End point description
    Venous blood samples for analysis of clinical chemistry, haematology and coagulation parameters and urine samples were collected and analysed.
    End point type
    Primary
    End point timeframe
    From Visit 1 (Screening) to Visit 8 (Follow-up).
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    25
    7
    Units: No of clinically significant (CS) values
        Clinical chemistry
    13
    0
        Haematology
    0
    0
        Coagulation
    0
    0
        Urine
    1
    0
    No statistical analyses for this end point

    Primary: Vital signs - Diastolic blood pressure

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    End point title
    		 Vital signs - Diastolic blood pressure [9]
    End point description
    Systolic/diastolic blood pressure and pulse were measured in the supine position after 5 min of rest. There were no clinically relevant mean changes over time with regards to any of the vital signs parameters evaluated and no individual abnormal values assessed as clinically significant.
    End point type
    Primary
    End point timeframe
    From Visit 1 (Screening) to Visit 8 (Follow-up).
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    25 [10]
    7 [11]
    Units: mmHg
    arithmetic mean (standard deviation)
        Visit 1, Screening
    77.0 ± 9.6
    70.9 ± 6.0
        Visit 6, Day 14
    75.4 ± 8.7
    70.4 ± 9.4
        Visit 8, Day 29
    78.2 ± 9.8
    65.8 ± 5.9
        Visit 9, Follow-up
    78.9 ± 11.6
    72.8 ± 14.0
    Notes
    [10] - Screening: N=25 Visit 6: N=23 Visit 8: N=23 Visit 9: N=24
    [11] - Screening: N=7 Visit 6: N=7 Visit 8: N=6 Visit 9: N=6
    No statistical analyses for this end point

    Primary: Vital signs - Pulse

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    End point title
    		 Vital signs - Pulse [12]
    End point description
    Systolic/diastolic blood pressure and pulse were measured in the supine position after 5 min of rest. There were no clinically relevant mean changes over time with regards to any of the vital signs parameters evaluated and no individual abnormal values assessed as clinically significant.
    End point type
    Primary
    End point timeframe
    From Visit 1 (Screening) to Visit 8 (Follow-up).
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    25 [13]
    7 [14]
    Units: beats/min
    arithmetic mean (standard deviation)
        Visit 1, Screening
    63.8 ± 7.5
    62.9 ± 5.6
        Visit 6, Day 14
    67.2 ± 11.3
    66.1 ± 11.9
        Visit 8, Day 29
    61.3 ± 8.5
    62.5 ± 11.7
        Visit 9, Follow-up
    64.0 ± 12.4
    63.3 ± 10.3
    Notes
    [13] - Visit 1: N=25 Visit 6: N=23 Visit 8: N=23 Visit 9: N=24
    [14] - Visit 1: N=7 Visit 6: N=7 Visit 8: N=6 Visit 9: N=6
    No statistical analyses for this end point

    Secondary: Unified Parkinson’s Disease Rating Scale (UPDRS)

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    End point title
    		 Unified Parkinson’s Disease Rating Scale (UPDRS)
    End point description
    The objective was to evaluate the effects of IRL752 on symptoms of PD assessed with Unified Parkinson’s Disease Rating Scale (UPDRS) part 1-4, as compared to placebo. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    24 [15]
    7 [16]
    Units: Score
    arithmetic mean (standard deviation)
        1. Mention, Behavior and Mood - Day 1
    5.8 ± 1.7
    5.6 ± 2.3
        1. Mention, Behavior and Mood - Day 28
    5.2 ± 2.1
    5.0 ± 3.0
        2. Activities of daily living - Day 1
    15.8 ± 6.7
    20.6 ± 6.8
        2. Activities of daily living - Day 28
    15.7 ± 5.9
    20.0 ± 7.3
        3. Motor examination - Day 1
    30.3 ± 11.1
    31.3 ± 13.5
        3. Motor examination - Day 28
    29.7 ± 11.8
    28.2 ± 15.3
        4. Complication of therapy - Day 1
    4.5 ± 2.2
    5.1 ± 3.4
        4. Complication of therapy - Day 28
    4.4 ± 2.9
    4.5 ± 3.5
    Notes
    [15] - Day 1: 24 Day 28: 23
    [16] - Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: Timed Up and Go (TUG)

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    End point title
    		 Timed Up and Go (TUG)
    End point description
    The objective was to evaluate the effects of IRL752 on postural control and walking speed assessed with Timed Up and Go (TUG) test, as compared to placebo. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    24 [17]
    7 [18]
    Units: seconds
    arithmetic mean (standard deviation)
        Day 1
    15.7 ± 17.2
    13.6 ± 4.5
        Day 28
    19.1 ± 40.2
    10.9 ± 1.9
    Notes
    [17] - Day 1: 24 Day 28:23
    [18] - Day 1: 7 Day 28:6
    No statistical analyses for this end point

    Secondary: Freezing of Gait Questionnaire (FOGQ)

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    End point title
    		 Freezing of Gait Questionnaire (FOGQ)
    End point description
    The objective was to evaluate the effects of IRL752 on freezing of gait assessed with the Freezing of Gait Questionnaire (FOGQ), as compared to placebo. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    24 [19]
    7 [20]
    Units: score
    arithmetic mean (standard deviation)
        Day 1
    8.7 ± 6.2
    14.3 ± 4.8
        Day 28
    7.8 ± 5.1
    13.8 ± 2.9
    Notes
    [19] - Day 1: 24 Day 28: 23
    [20] - Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: CANTAB - Motor Screening: Mean Latency

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    End point title
    		 CANTAB - Motor Screening: Mean Latency
    End point description
    The objective was to evaluate the effects of IRL752 on cognitive functions assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), as compared to placebo, including: - Motor Screening task - Reaction Time (RTI) task - Spatial Working Memory (SWM) task - Planning and executive function test, One Touch Stockings of Cambridge (OTS) Data based on FAS population. Motor Screening - Mean Latency: The mean latency from the display of a stimulus to a correct response to that stimulus during assessment trials.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    23 [21]
    7 [22]
    Units: msec
    arithmetic mean (standard deviation)
        Screening
    1413.6 ± 647.1
    1128.1 ± 258.8
        Day 1
    1382.8 ± 664.9
    1235.6 ± 295.7
        Day 28
    1392.4 ± 708.7
    1012.8 ± 254.2
    Notes
    [21] - Screening: 23 Day 1: 24 Day 28: 22
    [22] - Screening: 7 Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: CANTAB - Motor Screening: Incorrect responses

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    End point title
    		 CANTAB - Motor Screening: Incorrect responses
    End point description
    The objective was to evaluate the effects of IRL752 on cognitive functions assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), as compared to placebo, including: - Motor Screening task - Reaction Time (RTI) task - Spatial Working Memory (SWM) task - Planning and executive function test, One Touch Stockings of Cambridge (OTS) Motor Screening - Incorrect responses: The total number of assessment trials on which the subject failed to make a correct response. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    23 [23]
    7 [24]
    Units: number of assessment trials
    arithmetic mean (standard deviation)
        Screening
    0.1 ± 0.5
    0.0 ± 0.0
        Day 1
    0.5 ± 1.1
    0.0 ± 0.0
        Day 28
    0.3 ± 1.3
    0.0 ± 0.0
    Notes
    [23] - Screening: 23 Day 1: 24 Day 28: 22
    [24] - Screening: 7 Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: CANTAB - Motor Screening: Correct responses

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    End point title
    		 CANTAB - Motor Screening: Correct responses
    End point description
    The objective was to evaluate the effects of IRL752 on cognitive functions assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), as compared to placebo, including: - Motor Screening task - Reaction Time (RTI) task - Spatial Working Memory (SWM) task - Planning and executive function test, One Touch Stockings of Cambridge (OTS) Motor Screening - Correct responses: The total number of assessment trials on which the subject made a correct response. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    23 [25]
    7 [26]
    Units: number of assessment trials
    arithmetic mean (standard deviation)
        Screening
    9.9 ± 0.5
    10.0 ± 0.0
        Day 1
    9.5 ± 1.1
    10.0 ± 0.0
        Day 28
    9.7 ± 1.3
    10.0 ± 0.0
    Notes
    [25] - Screening: 23 Day 1: 24 Day 28: 22
    [26] - Screening: 7 Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: CANTAB - RTI: Reaction time

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    End point title
    		 CANTAB - RTI: Reaction time
    End point description
    The objective was to evaluate the effects of IRL752 on cognitive functions assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), as compared to placebo, including: - Motor Screening task - Reaction Time (RTI) task - Spatial Working Memory (SWM) task - Planning and executive function test, One Touch Stockings of Cambridge (OTS) Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    21 [27]
    7 [28]
    Units: msec
    arithmetic mean (standard deviation)
        Reaction Time: Screening
    645.4 ± 328.1
    636.7 ± 154.5
        Reaction Time: Day 1
    750.0 ± 532.4
    579.2 ± 134.5
        Reaction Time: Day 28
    651.7 ± 308.0
    572.4 ± 122.2
        Movement Time: Screening
    540.9 ± 369.5
    567.2 ± 328.8
        Movement Time: Day 1
    762.5 ± 666.4
    463.1 ± 159.9
        Movement Time: Day 28
    621.5 ± 517.5
    466.6 ± 198.4
    Notes
    [27] - Screening: 21 Reaction Time Day 1: 23 Reaction Time Day 28: 21
    [28] - Screening: 7 Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: CANTAB - Spatial Working Memory (SWM): Total errors

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    End point title
    		 CANTAB - Spatial Working Memory (SWM): Total errors
    End point description
    The objective was to evaluate the effects of IRL752 on cognitive functions assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), as compared to placebo, including: - Motor Screening task - Reaction Time (RTI) task - Spatial Working Memory (SWM) task - Planning and executive function test, One Touch Stockings of Cambridge (OTS) Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    22 [29]
    7 [30]
    Units: score
    arithmetic mean (standard deviation)
        Screening
    31.4 ± 13.2
    26.7 ± 5.2
        Day 1
    28.3 ± 8.2
    28.0 ± 4.4
        Day 28
    27.7 ± 9.3
    30.8 ± 10.1
    Notes
    [29] - Screening: 22 Day 1: 23 Day 28: 20
    [30] - Screening: 7 Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: CANTAB - Spatial Working Memory (SWM): Within errors

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    End point title
    		 CANTAB - Spatial Working Memory (SWM): Within errors
    End point description
    The objective was to evaluate the effects of IRL752 on cognitive functions assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), as compared to placebo, including: - Motor Screening task - Reaction Time (RTI) task - Spatial Working Memory (SWM) task - Planning and executive function test, One Touch Stockings of Cambridge (OTS) SWM within errors: The number of times a subject revisits a box already shown to be empty during the same search. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    22 [31]
    7 [32]
    Units: score
    arithmetic mean (standard deviation)
        Screening
    6.7 ± 9.6
    3.9 ± 4.5
        Day 1
    4.3 ± 6.7
    3.7 ± 3.6
        Day 28
    3.9 ± 8.8
    5.5 ± 5.8
    Notes
    [31] - Screening: 22 Day 1: 23 Day 28: 20
    [32] - Screening: 7 Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: CANTAB - Spatial Working Memory (SWM): Between errors

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    End point title
    		 CANTAB - Spatial Working Memory (SWM): Between errors
    End point description
    The objective was to evaluate the effects of IRL752 on cognitive functions assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), as compared to placebo, including: - Motor Screening task - Reaction Time (RTI) task - Spatial Working Memory (SWM) task - Planning and executive function test, One Touch Stockings of Cambridge (OTS) SWM Between errors: The number of times the subject incorrectly revisits a box in which a token has previously been found. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    22 [33]
    7 [34]
    Units: score
    arithmetic mean (standard deviation)
        Screening
    29.0 ± 10.7
    26.0 ± 5.2
        Day 1
    27.1 ± 7.2
    27.3 ± 4.4
        Day 28
    26.7 ± 7.2
    29.7 ± 8.9
    Notes
    [33] - Screening: 22 Day 1: 23 Day 28: 20
    [34] - Screening: 7 Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: CANTAB - Spatial Working Memory (SWM): Strategy

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    End point title
    		 CANTAB - Spatial Working Memory (SWM): Strategy
    End point description
    The objective was to evaluate the effects of IRL752 on cognitive functions assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), as compared to placebo, including: - Motor Screening task - Reaction Time (RTI) task - Spatial Working Memory (SWM) task - Planning and executive function test, One Touch Stockings of Cambridge (OTS) SWM Strategy: The number of times a subject begins a new search pattern from the same box they started with previously. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    22 [35]
    7 [36]
    Units: score
    arithmetic mean (standard deviation)
        Screening
    9.5 ± 1.9
    9.3 ± 0.8
        Day 1
    9.4 ± 1.5
    10.3 ± 1.1
        Day 28
    9.6 ± 1.5
    9.8 ± 1.0
    Notes
    [35] - Screening: 22 Day 1: 23 Day 28: 20
    [36] - Screening: 7 Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: CANTAB - One Touch Stockings (OTS): First choice accuracy

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    End point title
    		 CANTAB - One Touch Stockings (OTS): First choice accuracy
    End point description
    The objective was to evaluate the effects of IRL752 on cognitive functions assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), as compared to placebo, including: - Motor Screening task - Reaction Time (RTI) task - Spatial Working Memory (SWM) task - Planning and executive function test, One Touch Stockings of Cambridge (OTS) OTS First choice accuracy: The total number of assessed trials where the subject choose the correct answer on the first attempt. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    20 [37]
    6 [38]
    Units: score
    arithmetic mean (standard deviation)
        Screening
    4.2 ± 2.9
    4.3 ± 1.4
        Day 1
    3.9 ± 4.0
    3.0 ± 1.1
        Day 28
    4.9 ± 3.0
    3.2 ± 1.1
    Notes
    [37] - Screening: 20 Day 1: 23 Day 28: 20
    [38] - Screening: 6 Day 1: 6 Day 28: 5
    No statistical analyses for this end point

    Secondary: CANTAB - One Touch Stockings: Median Latency Correct

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    End point title
    		 CANTAB - One Touch Stockings: Median Latency Correct
    End point description
    The objective was to evaluate the effects of IRL752 on cognitive functions assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), as compared to placebo, including: - Motor Screening task - Reaction Time (RTI) task - Spatial Working Memory (SWM) task - Planning and executive function test, One Touch Stockings of Cambridge (OTS) OTS Median Latency Correct: The median latency, measured from the appearance of the stocking balls until the correct box choice was made by the subject. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    20 [39]
    6 [40]
    Units: score
    arithmetic mean (standard deviation)
        Screening
    46399.0 ± 35576.8
    47776.5 ± 56226.5
        Day 1
    47512.7 ± 35512.9
    57887.8 ± 63752.6
        Day 28
    43590.2 ± 38919.0
    60184.4 ± 59576.5
    Notes
    [39] - Screening: 20 Day 1: 23 Day 28: 20
    [40] - Screening: 6 Day 1: 6 Day 28: 5
    No statistical analyses for this end point

    Secondary: Neuropsychiatric Inventory-12 (NPI-12)

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    End point title
    		 Neuropsychiatric Inventory-12 (NPI-12)
    End point description
    The objective was to evaluate the effects of IRL752 on neuropsychiatric symptoms assessed with Neuropsychiatric Inventory-12 (NPI-12), as compared to placebo. The NPI-12 is a clinical instrument for assessing behavioural and psychological symptoms in dementia in 12 domains [13]. It is based on an interview with the primary caregiver. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. Each domain is scored for frequency, severity and associated caregiver distress. A higher score represents a higher severity or caregiver distress. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline (screening) to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    24 [41]
    7 [42]
    Units: score
    arithmetic mean (standard deviation)
        Caregiver distress: Screening
    7.9 ± 5.5
    11.3 ± 8.0
        Caregiver distress: Day 29
    6.4 ± 5.8
    7.2 ± 7.9
        Severity: Screening
    16.3 ± 10.1
    12.3 ± 8.3
        Severity: Day 29
    14.5 ± 13.1
    10.3 ± 15.7
    Notes
    [41] - Screening: 24 Day 29: 23
    [42] - Screening: 7 Day 29: 6
    No statistical analyses for this end point

    Secondary: Clinician's Interview-Based Impression of Change Plus caregiver input (CIBIC-Plus)

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    End point title
    		 Clinician's Interview-Based Impression of Change Plus caregiver input (CIBIC-Plus)
    End point description
    The objective was to evaluate the effects of IRL752 on global function assessed with Clinician's Interview-Based Impression of Change Plus caregiver input (CIBIC-Plus), as compared to placebo. The CIBIC-Plus is a validated clinical instrument used to measure change in global function through an interview with patients and their caregivers. Patients are assessed on a 7-point scale, “1=Very much improved” to “7=Marked worsening”, based on information from four major categories: General, Mental/Cognitive State, Behaviour, and ADLs. Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    At end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    23
    6
    Units: Number of observations
        Subject's interview: 2. Much improved
    0
    1
        Subject's interview: 3. Minimally improved
    5
    1
        Subject's interview: 4. No change
    11
    4
        Subject's interview: 5. Minimal worsening
    4
    0
        Subject's interview: 6. Moderate worsening
    3
    0
        Informant's interview: 2. Much improved
    1
    0
        Informant's interview: 3. Minimally improved
    4
    2
        Informant's interview: 4. No change
    12
    4
        Informant's interview: 5. Minimal worsening
    4
    0
        Informant's interview: 6. Moderate worsening
    1
    0
        Informant's interview: 7. Marked worsening
    1
    0
        Overall score: 3. Minimally improved
    5
    2
        Overall score: 4. No change
    14
    4
        Overall score: 5. Minimal worsening
    3
    0
        Overall score: 6. Moderate worsening
    1
    0
    No statistical analyses for this end point

    Secondary: EEG

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    End point title
    		 EEG
    End point description
    The objective was to evaluate the effects of IRL752 on electroencephalography (EEG) pattern changes as compared to placebo. Resting EEG recordings were captured with no less than 5 min of technically satisfactory, artefact free recording. EEGs were captured at Baseline (Visit 2) and at end of treatment (Visit 7). Data based on FAS population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    End point values
    		 IRL752 Placebo
    Number of subjects analysed
    24 [43]
    7 [44]
    Units: Ach index
    arithmetic mean (standard deviation)
        Day 1
    78.1 ± 18.3
    79.0 ± 10.4
        Day 28
    77.7 ± 18.3
    82.7 ± 9.4
    Notes
    [43] - Day 1: 24 Day 28: 23
    [44] - Day 1: 7 Day 28: 6
    No statistical analyses for this end point

    Secondary: Exposure of IRL752

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    End point title
    		 Exposure of IRL752 [45]
    End point description
    The objective was to examine the exposure of IRL752 in patients with PDD. Venous blood samples (approximately 5 mL) for the determination of concentrations of IRL752 in plasma were collected at specified time-points.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment.
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Exposure is not applicable for the placebo group.
    End point values
    		 IRL752
    Number of subjects analysed
    24 [46]
    Units: nM
    arithmetic mean (standard deviation)
        Day 1: Pre-dose
    0 ± 0
        Day 1: 2 hours
    1380 ± 568.8
        Day 14: Pre-dose
    1822 ± 916.8
        Day 14: 2 hours
    4275 ± 1717
        Day 28: Pre-dose
    1515 ± 517.5
        Day 28: 2 hours
    3969 ± 1354
    Notes
    [46] - Day 1: 24 Day 14: 23 Day 28: 23
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing the ICF (Visit 1; Screening) until the follow-up assessment (Visit 8). AEs occurring after first administration of IMP (TEAEs) is presented below.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    IRL752 Steady state
    Reporting group description
    		 25 patients were treated with IRL752.

    Reporting group title
    Placebo Steady state
    Reporting group description
    		 7 patients were treated with placebo.

    Reporting group title
    IRL752 Titration
    Reporting group description
    		 25 patients were treated with IRL752.

    Reporting group title
    Placebo Titration
    Reporting group description
    		 7 patients were treated with placebo.

    Serious adverse events
    		 IRL752 Steady state Placebo Steady state IRL752 Titration Placebo Titration
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 7 (14.29%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Collum fracture
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 7 (14.29%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Freeze x 3 during night
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (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
    Psychiatric disorders
    Confused
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (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
    Infections and infestations
    Infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 IRL752 Steady state Placebo Steady state IRL752 Titration Placebo Titration
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 23 (47.83%)
    1 / 7 (14.29%)
    16 / 25 (64.00%)
    1 / 7 (14.29%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Confusional state
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Depression
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hallucination
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Irritability
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Cardiac disorders
    Atrioventricular block
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 7 (14.29%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cognitive disorder
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    3 / 25 (12.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Parkinsonism
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tremor
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    2 / 25 (8.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Xerophthalmia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    2 / 25 (8.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Constipation
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 7 (14.29%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Proctalgia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Skin reaction
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    2 / 25 (8.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Posture abnormal
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    0 / 25 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
    1 / 25 (4.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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