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    Clinical Trial Results:
    A Phase II, randomized, double-blind, parallel group dose finding study of single oral doses of moxidectin in adults with scabies

    Summary
    EudraCT number
    		 2019-001775-37
    Trial protocol
    		 FR   AT  
    Global end of trial date
    28 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Mar 2023
    First version publication date
    16 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MDGH-MOX-2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03905265
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medicines Development for Global Health Limited
    Sponsor organisation address
    Level 1, 18 Kavanagh Street, Southbank, Australia,
    Public contact
    Clinical Project Manager, Medicines Development for Global Health, +61 399122400, MDGH-MOX-2001@medicinesdevelopment.com
    Scientific contact
    Clinical Project Manager, Medicines Development for Global Health, +61 399122400, MDGH-MOX-2001@medicinesdevelopment.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the trial were to identify an optimal dose of moxidectin for the treatment of scabies and evaluate the safety of moxidectin in adults infected with scabies.
    Protection of trial subjects
    Approval for the conduct of the study was obtained from the Independent Ethics Committees associated with each study site before study commencement. The protocol, all material that was provided to the subjects such as the Informed Consent Form, subject information sheets and advertising text, and all amendments made to the protocol and/or consent forms after receipt of initial approval were submitted to the Independent Ethics Committee associated with each study site prior to use. The Investigators ensured that this study was conducted in full conformance with the protocol, the latest version of the Declaration of Helsinki (and its amendments), and with the requirements of national drug and data protection laws of the countries in which the research was conducted. The Sponsor and the Investigators ensured strict adherence to the provisions of Good Clinical Practice (GCP) and all applicable and national regulations. The International Conference on Harmonization (ICH) guidelines was applied, at a minimum.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Aug 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Australia: 8
    Worldwide total number of subjects
    22
    EEA total number of subjects
    14
    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)
    19
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Australia and Europe. Screening commenced in January 2020. The last study visit occurred on 28 Feb 2022.

    Pre-assignment
    Screening details
    		 27 participants were screened.

    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, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 2 mg moxidectin
    Arm description
    		 Participants received a single oral dose of 2 mg moxidectin on Day 0
    Arm type
    		 Experimental

    Investigational medicinal product name
    Moxidectin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each participant received a single dose of moxidectin at the specified dose on Day 0, comprised of active study drug (moxidectin 2 mg tablets) and a sufficient quantity of placebo tablets to maintain the blind, up to a maximum of 18 tablets.

    Arm title
    		 8 mg moxidectin
    Arm description
    		 Participants received a single oral dose of 8 mg moxidectin on Day 0
    Arm type
    		 Experimental

    Investigational medicinal product name
    Moxidectin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each participant received a single dose of moxidectin at the specified dose on Day 0, comprised of active study drug (moxidectin 2 mg tablets) and a sufficient quantity of placebo tablets to maintain the blind, up to a maximum of 18 tablets.

    Arm title
    		 20 mg moxidectin
    Arm description
    		 Participants received a single oral dose of 20 mg moxidectin on Day 0
    Arm type
    		 Experimental

    Investigational medicinal product name
    Moxidectin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each participant received a single dose of moxidectin at the specified dose on Day 0, comprised of active study drug (moxidectin 2 mg tablets) and a sufficient quantity of placebo tablets to maintain the blind, up to a maximum of 18 tablets.

    Arm title
    		 36 mg moxidectin
    Arm description
    		 Participants received a single oral dose of 36 mg moxidectin on Day 0
    Arm type
    		 Experimental

    Investigational medicinal product name
    Moxidectin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each participant received a single dose of moxidectin at the specified dose on Day 0, comprised of active study drug (moxidectin 2 mg tablets) and a sufficient quantity of placebo tablets to maintain the blind, up to a maximum of 18 tablets.

    Number of subjects in period 1
    		2 mg moxidectin 8 mg moxidectin 20 mg moxidectin 36 mg moxidectin
    Started
    4
    4
    6
    8
    Completed
    3
    3
    6
    8
    Not completed
    1
    1
    0
    0
         Consent withdrawn by subject
    1
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    2 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 2 mg moxidectin on Day 0

    Reporting group title
    8 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 8 mg moxidectin on Day 0

    Reporting group title
    20 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 20 mg moxidectin on Day 0

    Reporting group title
    36 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 36 mg moxidectin on Day 0

    Reporting group values
    		 2 mg moxidectin 8 mg moxidectin 20 mg moxidectin 36 mg moxidectin Total
    Number of subjects
    		 4 4 6 8 22
    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)
    		 3 3 6 7 19
        From 65-84 years
    		 1 1 0 1 3
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.5 ( 18.88 ) 45.3 ( 15.50 ) 27.2 ( 9.33 ) 29.4 ( 17.26 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 1 4 4 13
        Male
    		 0 3 2 4 9
    Subject analysis sets

    Subject analysis set title
    Enrolled Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Enrolled Set included all subjects who were randomized irrespective of whether they received the study drug.

    Subject analysis set title
    Per Protocol Analysis Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol Analysis Set (PPAS) included all subjects exposed to study drug without any major protocol deviations that could have confounded the assessment and/or interpretation of the analytic results. Subjects in the PPAS were analyzed according to the actual dose of study drug received regardless of their randomized dose group. In general, PPAS subjects with missing data for a specific analysis were excluded from that analysis.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Analysis Set (SfAS) included all subjects exposed to study drug. Subjects were analyzed according to the actual dose of study drug received regardless of their randomized dose group. Unless otherwise noted, the SfAS was used for all safety analyses.

    Subject analysis set title
    Pharmacokinetic Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Pharmacokinetic (PK) Analysis Set included subjects in the Enrolled Analysis Set with at least one blood sample that was collected to assess moxidectin PK concentrations.

    Subject analysis sets values
    		 Enrolled Set Per Protocol Analysis Set Safety Analysis Set Pharmacokinetic Analysis Set
    Number of subjects
    22
    15
    22
    22
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.8 ( 16.73 )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    2 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 2 mg moxidectin on Day 0

    Reporting group title
    8 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 8 mg moxidectin on Day 0

    Reporting group title
    20 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 20 mg moxidectin on Day 0

    Reporting group title
    36 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 36 mg moxidectin on Day 0

    Subject analysis set title
    Enrolled Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Enrolled Set included all subjects who were randomized irrespective of whether they received the study drug.

    Subject analysis set title
    Per Protocol Analysis Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol Analysis Set (PPAS) included all subjects exposed to study drug without any major protocol deviations that could have confounded the assessment and/or interpretation of the analytic results. Subjects in the PPAS were analyzed according to the actual dose of study drug received regardless of their randomized dose group. In general, PPAS subjects with missing data for a specific analysis were excluded from that analysis.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Analysis Set (SfAS) included all subjects exposed to study drug. Subjects were analyzed according to the actual dose of study drug received regardless of their randomized dose group. Unless otherwise noted, the SfAS was used for all safety analyses.

    Subject analysis set title
    Pharmacokinetic Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Pharmacokinetic (PK) Analysis Set included subjects in the Enrolled Analysis Set with at least one blood sample that was collected to assess moxidectin PK concentrations.

    Primary: Subject Incidence of Treatment-Emergent Adverse Events

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    End point title
    		 Subject Incidence of Treatment-Emergent Adverse Events [1]
    End point description
    Treatment emergent adverse events (TEAEs) were defined as adverse events that started or worsened, on or after the start of the administration of investigational product.
    End point type
    Primary
    End point timeframe
    Up to and including Week 12.
    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: Study data was analyzed in a descriptive manner and sample size was not based on formal power considerations with respect to statistical hypothesis testing.
    End point values
    		 2 mg moxidectin 8 mg moxidectin 20 mg moxidectin 36 mg moxidectin Safety Analysis Set
    Number of subjects analysed
    4
    4
    6
    8
    22
    Units: Number of subjects
        Any TEAE
    4
    4
    6
    8
    22
        Serious TEAEs
    0
    0
    0
    1
    1
        Serious study-drug related TEAEs
    0
    0
    0
    0
    0
        TEAEs leading to withdrawal
    0
    0
    0
    0
    0
        TEAEs leading to death
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Time to death of adult scabies mites

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    End point title
    		 Time to death of adult scabies mites [2]
    End point description
    Efficacy at Day 28 will be determined by death of the mites, defined as the degradation (loss of internal and/or external anatomic structures) of the adult mite observed by reflectance confocal microscopy.
    End point type
    Primary
    End point timeframe
    Mites were assessed by reflectance confocal microscopy (RCM) at Hours 4, 8, 24, 48 and 72 and Days 7, 14 and 28 in not less than two lesions nominated pre-treatment. No subject had more than 2 mites assessed by RCM.
    Notes
    [2] - 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: Study data was analyzed in a descriptive manner and sample size was not based on formal power considerations with respect to statistical hypothesis testing.
    End point values
    		 2 mg moxidectin 8 mg moxidectin 20 mg moxidectin 36 mg moxidectin Per Protocol Analysis Set
    Number of subjects analysed
    1
    3
    4
    7
    15
    Units: hours
        arithmetic mean (standard deviation)
    671.3 ( 0 )
    215.1 ( 219.4 )
    229.2 ( 128.6 )
    251.7 ( 196.6 )
    266.4 ( 204.8 )
    No statistical analyses for this end point

    Primary: Severity of Treatment Emergent Adverse Events

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    End point title
    		 Severity of Treatment Emergent Adverse Events [3]
    End point description
    Treatment emergent adverse events (TEAEs) were defined as adverse events that started, or worsened, on or after the start of the administration of investigational product. If a subject experienced more than one TEAE, the subject is counted once at the most severe event.
    End point type
    Primary
    End point timeframe
    Up to and including Week 12.
    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: Study data was analyzed in a descriptive manner and sample size was not based on formal power considerations with respect to statistical hypothesis testing.
    End point values
    		 2 mg moxidectin 8 mg moxidectin 20 mg moxidectin 36 mg moxidectin Safety Analysis Set
    Number of subjects analysed
    4
    4
    6
    8
    22
    Units: Number of subjects
        Grade 1 TEAEs
    1
    1
    4
    5
    11
        Grade 2 TEAEs
    3
    3
    2
    3
    11
        Grade 3 TEAEs
    0
    0
    0
    0
    0
        Grade 4 TEAEs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Proportion of Subjects with 100% Dead Adult Scabies Mites on Day 28

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    End point title
    		 Proportion of Subjects with 100% Dead Adult Scabies Mites on Day 28 [4]
    End point description
    Efficacy at Day 28 will be determined by death of the mites, defined as the degradation (loss of internal and/or external anatomic structures) of the adult mite observed by reflectance confocal microscopy.
    End point type
    Primary
    End point timeframe
    Mites were assessed by reflectance confocal microscopy (RCM) at Hours 4, 8, 24, 48 and 72 and Days 7, 14 and 28 in not less than two lesions nominated pre-treatment. No subject had more than 2 mites assessed by RCM.
    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: Study data was analyzed in a descriptive manner and sample size was not based on formal power considerations with respect to statistical hypothesis testing.
    End point values
    		 2 mg moxidectin 8 mg moxidectin 20 mg moxidectin 36 mg moxidectin Per Protocol Analysis Set
    Number of subjects analysed
    1
    3
    4
    7
    15
    Units: Percentage of subjects
    0
    100
    100
    100
    93
    No statistical analyses for this end point

    Secondary: Area under the Concentration-Time Curve over 28 days (AUC0-28) of moxidectin

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    End point title
    		 Area under the Concentration-Time Curve over 28 days (AUC0-28) of moxidectin
    End point description
    Pharmacokinetic parameters were calculated were derived using non-compartmental methods. AUC calculation method was linear up log down.
    End point type
    Secondary
    End point timeframe
    Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h)
    End point values
    		 2 mg moxidectin 8 mg moxidectin 20 mg moxidectin 36 mg moxidectin Pharmacokinetic Analysis Set
    Number of subjects analysed
    4
    4
    6
    8
    0 [5]
    Units: hr*ng/ml
        geometric mean (geometric coefficient of variation)
    408 ( 82.5 )
    1970 ( 30.0 )
    4670 ( 41.1 )
    7430 ( 37.6 )
    ( )
    Notes
    [5] - AUC0-28 was not calculated for all subjects
    No statistical analyses for this end point

    Secondary: Maximum observed plasma concentration of moxidectin

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    End point title
    		 Maximum observed plasma concentration of moxidectin
    End point description
    Pharmacokinetic parameters were calculated were derived using non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h)
    End point values
    		 2 mg moxidectin 8 mg moxidectin 20 mg moxidectin 36 mg moxidectin Pharmacokinetic Analysis Set
    Number of subjects analysed
    4
    4
    6
    8
    0 [6]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    21.0 ( 47.1 )
    73.5 ( 42.0 )
    207 ( 44.9 )
    277 ( 26.9 )
    ( )
    Notes
    [6] - Overall Cmax was not determined
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 to Week 12, inclusive.
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. TEAEs that occurred in more than 5% of subjects overall are reported. The most commonly occurring TEAEs are defined as those occurring in two or more subjects (5%) overall.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    2 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 2 mg moxidectin on Day 0

    Reporting group title
    8 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 8 mg moxidectin on Day 0

    Reporting group title
    20 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 20 mg moxidectin on Day 0

    Reporting group title
    36 mg moxidectin
    Reporting group description
    		 Participants received a single oral dose of 36 mg moxidectin on Day 0

    Reporting group title
    Overall
    Reporting group description
    		 All subjects

    Serious adverse events
    		 2 mg moxidectin 8 mg moxidectin 20 mg moxidectin 36 mg moxidectin Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 22 (4.55%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 2 mg moxidectin 8 mg moxidectin 20 mg moxidectin 36 mg moxidectin Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    6 / 6 (100.00%)
    8 / 8 (100.00%)
    22 / 22 (100.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    4 / 22 (18.18%)
         occurrences all number
    1
    0
    1
    3
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    1
    0
    2
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    1
    0
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    3 / 8 (37.50%)
    4 / 22 (18.18%)
         occurrences all number
    0
    0
    1
    3
    4
    Eczema
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 4 (50.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    3 / 22 (13.64%)
         occurrences all number
    0
    2
    0
    1
    3
    Rash papular
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    2 / 22 (9.09%)
         occurrences all number
    2
    0
    0
    1
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    1
    0
    2
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    2 / 4 (50.00%)
    3 / 4 (75.00%)
    4 / 6 (66.67%)
    5 / 8 (62.50%)
    14 / 22 (63.64%)
         occurrences all number
    2
    3
    5
    6
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2020
    The protocol was amended to permit ongoing data review by a Protocol Steering Committee and provision for opening the 36 mg moxidectin dose cohort and/or closing recruitment to any of the moxidectin dose cohorts. The amendment also contained provisions for modifying scheduled procedures due to the ongoing novel SARS-CoV-2 (COVID 19) pandemic.

    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.
    Small number of subjects, especially in the Per-Protocol Analysis set, confounds interpretation of some study results.
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