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    Clinical Trial Results:
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines

    Summary
    EudraCT number
    2014-005302-38
    Trial protocol
    DE  
    Global end of trial date
    25 Jan 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Jan 2024
    First version publication date
    18 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MT10109L-006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03732833
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    IND Number: 121473
    Sponsors
    Sponsor organisation name
    Medytox Inc
    Sponsor organisation address
    78, Gangni 1-gil, Ochang-eup, Cheongwon-gu, Cheongju-si, Korea, Republic of, 28126
    Public contact
    Young Ryu, Medytox Inc, 82 2-6901-5424,
    Scientific contact
    Gyungjin Heo, Medytox Inc, 82 2-6901-5839, gjheo@medytox.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
    29 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy between 24 U MT10109L and placebo for the treatment of LCL (with or without concurrent 20 U treatment of GL) in participants with moderate to severe LCL and GL. The total global enrollment (as presented in the "Population of Trial Subjects" below was 424, which included the Intent-To-Treat population. However, all primary and secondary efficacy analyses for EU regulatory endpoints reported here are using the mITT population that included a total of 350 participants (USA - 235 ; Canada -76 and; Germany - 39).
    Protection of trial subjects
    The study protocol, all study protocol amendments, written study participant information, informed consent form (ICF), Investigator’s Brochure (IB) and any other relevant documents were reviewed and approved by an independent ethics committee (IEC) or institutional review board (IRB) at each study center. The study was conducted in accordance with the protocol, the ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonization (ICH)/Good Clinical Practice (GCP) and other Guidelines, and applicable laws and regulations. An ICF approved by each study center’s IEC/IRB was signed by the participant or their legally authorized representative and the authorized person obtaining the ICF before the participant was entered in the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Nov 2018
    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
    Canada: 93
    Country: Number of subjects enrolled
    United States: 279
    Country: Number of subjects enrolled
    Germany: 52
    Worldwide total number of subjects
    424
    EEA total number of subjects
    52
    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)
    393
    From 65 to 84 years
    30
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were screened and recruited at sites in US, Canada and Germany. The data described here is for the Intent-to-Treat population. The Intent-to-treat (ITT) population consisted of all randomized participants.

    Pre-assignment
    Screening details
    424 met the inclusion/exclusion criterial and were randomized.

    Period 1
    Period 1 title
    First treatment
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Randomization and double-blinding were used to minimize bias arising from the assignment of participants to treatment groups and the expectations of participants, investigators, and individuals collecting data.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving the placebo in both LCL and GL areas.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. Placebo - 0 U per 0.1 ml.

    Arm title
    MT10109L in LCL + Placebo in GL
    Arm description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and placebo the GL area.
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. Placebo - 0 U per 0.1 ml. MT10109L - 4 U per 0.1 ml

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. Placebo - 0 U per 0.1 ml.

    Arm title
    MT10109L in LCL + MT10109L in GL
    Arm description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and MT10109L the GL area.
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. MT10109L - 4 U per 0.1 ml

    Number of subjects in period 1
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Started
    86
    171
    167
    Completed
    76
    153
    157
    Not completed
    10
    18
    10
         Consent withdrawn by subject
    5
    7
    4
         Physician decision
    1
    3
    -
         Adverse event, non-fatal
    -
    1
    1
         Pregnancy
    -
    1
    -
         Early termination, COVID-19
    1
    4
    2
         Lost to follow-up
    3
    2
    3
    Period 2
    Period 2 title
    Re-treatment 1
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Randomization and double-blinding were used to minimize bias arising from the assignment of participants to treatment groups and the expectations of participants, investigators, and individuals collecting data.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving the placebo in both LCL and GL areas.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. Placebo - 0 U per 0.1 ml.

    Arm title
    MT10109L in LCL + Placebo in GL
    Arm description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and placebo the GL area.
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. Placebo - 0 U per 0.1 ml. MT10109L - 4 U per 0.1 ml

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. Placebo - 0 U per 0.1 ml.

    Arm title
    MT10109L in LCL + MT10109L in GL
    Arm description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and MT10109L the GL area.
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. MT10109L - 4 U per 0.1 ml

    Number of subjects in period 2 [1]
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Started
    75
    150
    155
    Completed
    69
    141
    150
    Not completed
    6
    9
    5
         Physician decision
    1
    -
    1
         Consent withdrawn by subject
    4
    5
    2
         COVID-19
    1
    1
    1
         Lost to follow-up
    -
    3
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only participants from period 1 (first treatment), who met the protocol-defined re-treatment criteria, were eligible to enter period 2 (re-treatment 1)
    Period 3
    Period 3 title
    Re-treatment 2
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Randomization and double-blinding were used to minimize bias arising from the assignment of participants to treatment groups and the expectations of participants, investigators, and individuals collecting data.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving the placebo in both LCL and GL areas.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate, Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. Placebo - 0 U per 0.1 ml.

    Arm title
    MT10109L in LCL + Placebo in GL
    Arm description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and placebo the GL area.
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. Placebo - 0 U per 0.1 ml. MT10109L - 4 U per 0.1 ml

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. Placebo - 0 U per 0.1 ml.

    Arm title
    MT10109L in LCL + MT10109L in GL
    Arm description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and MT10109L the GL area.
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The volume was 0.1 ml per injection. MT10109L - 4 U per 0.1 ml

    Number of subjects in period 3 [2]
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Started
    53
    108
    108
    Completed
    51
    102
    106
    Not completed
    2
    6
    2
         Consent withdrawn by subject
    2
    1
    2
         Adverse event, non-fatal
    -
    2
    -
         COVID-19
    -
    2
    -
         Pregnancy
    -
    1
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only participants from period 2 (re-treatment 1), who met the protocol-defined re-treatment criteria, were eligible to enter period 3 (re-treatment 2)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving the placebo in both LCL and GL areas.

    Reporting group title
    MT10109L in LCL + Placebo in GL
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and placebo the GL area.

    Reporting group title
    MT10109L in LCL + MT10109L in GL
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and MT10109L the GL area.

    Reporting group values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL Total
    Number of subjects
    86 171 167 424
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    80 156 157 393
        From 65-84 years
    5 15 10 30
        85 years and over
    1 0 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    48.6 ( 12.32 ) 47.7 ( 11.56 ) 49.1 ( 10.37 ) -
    Gender categorical
    Units: Subjects
        Female
    71 143 141 355
        Male
    15 28 26 69
    Subject analysis sets

    Subject analysis set title
    Demographic and other Baseline Characteristics - ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    424 participants were included in the Intent-To-Treat (ITT) population (86 participants in the placebo group; 171 participants in the MT10109L in LCL + Placebo in GL; and 167 participants in the MT10109L in LCL + MT10109L in GL group).

    Subject analysis set title
    Demographic and other Baseline Characteristics - mITT
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    350 participants were included in the modified Intent-To-Treat (ITT) population (70 participants in the placebo group; 138 participants in the MT10109L in LCL + Placebo in GL; and 142 participants in the MT10109L in LCL + MT10109L in GL group).

    Subject analysis sets values
    Demographic and other Baseline Characteristics - ITT Demographic and other Baseline Characteristics - mITT
    Number of subjects
    424
    350
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    393
    324
        From 65-84 years
    30
    25
        85 years and over
    1
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    48.5 ( 11.26 )
    48.8 ( 11.07 )
    Gender categorical
    Units: Subjects
        Female
    355
    297
        Male
    69
    53

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving the placebo in both LCL and GL areas.

    Reporting group title
    MT10109L in LCL + Placebo in GL
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and placebo the GL area.

    Reporting group title
    MT10109L in LCL + MT10109L in GL
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and MT10109L the GL area.
    Reporting group title
    Placebo
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving the placebo in both LCL and GL areas.

    Reporting group title
    MT10109L in LCL + Placebo in GL
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and placebo the GL area.

    Reporting group title
    MT10109L in LCL + MT10109L in GL
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and MT10109L the GL area.
    Reporting group title
    Placebo
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving the placebo in both LCL and GL areas.

    Reporting group title
    MT10109L in LCL + Placebo in GL
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and placebo the GL area.

    Reporting group title
    MT10109L in LCL + MT10109L in GL
    Reporting group description
    The overall participants were randomized 2:2:1 to the following arms to receive: • Placebo in both LCL and GL areas, or • MT10109L 24 U (24 U in LCL area, placebo in GL area), or • MT10109L 44 U (24 U in LCL area and 20 U in GL area), This arm describes the data for participants receiving MT10109L in the LCL area and MT10109L the GL area.

    Subject analysis set title
    Demographic and other Baseline Characteristics - ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    424 participants were included in the Intent-To-Treat (ITT) population (86 participants in the placebo group; 171 participants in the MT10109L in LCL + Placebo in GL; and 167 participants in the MT10109L in LCL + MT10109L in GL group).

    Subject analysis set title
    Demographic and other Baseline Characteristics - mITT
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    350 participants were included in the modified Intent-To-Treat (ITT) population (70 participants in the placebo group; 138 participants in the MT10109L in LCL + Placebo in GL; and 142 participants in the MT10109L in LCL + MT10109L in GL group).

    Primary: Co-primary Efficacy endpoint: The % of Participants Achieving None or Mild on the FWS According to Investigator Assessment of LCL Severity at Maximum Smile at Day 30 of Treatment Cycle 1

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    End point title
    Co-primary Efficacy endpoint: The % of Participants Achieving None or Mild on the FWS According to Investigator Assessment of LCL Severity at Maximum Smile at Day 30 of Treatment Cycle 1
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The data here presents the percentage of participants who had LCL severity at maximum smile of none or mild based on Investigator FWS rating at Cycle 1 Day 30. FWS is 4-point grading scale, where 0=none, 1=mild, 2=moderate, and 3=severe.
    End point type
    Primary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    70
    138
    142
    Units: Participants
    3
    78
    86
    Statistical analysis title
    MT10109L in LCL vs Placebo
    Comparison groups
    MT10109L in LCL + Placebo in GL v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [1]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - The equality of the proportions of responders was analyzed using the CMH tests stratified by LCL baseline severity.
    Statistical analysis title
    MT10109L in LCL plus MT10109L in GL vs Placebo
    Comparison groups
    MT10109L in LCL + MT10109L in GL v Placebo
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - The equality of the proportions of responders was analyzed using the CMH tests stratified by LCL baseline severity.

    Primary: Primary Efficacy endpoint: The % of Participants Achieving None or Mild on the FWS According to Participant Assessment of LCL Severity at Maximum Smile at Day 30 of Treatment Cycle 1

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    End point title
    Primary Efficacy endpoint: The % of Participants Achieving None or Mild on the FWS According to Participant Assessment of LCL Severity at Maximum Smile at Day 30 of Treatment Cycle 1
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The data here presents the percentage of participants who had LCL severity at maximum smile of none or mild based on participant FWS rating at Cycle 1 Day 30. FWS is 4-point grading scale, where 0=none, 1=mild, 2=moderate, and 3=severe.
    End point type
    Primary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    70
    138
    142
    Units: Participants
    2
    60
    67
    Statistical analysis title
    MT10109L in LCL vs Placebo
    Comparison groups
    Placebo v MT10109L in LCL + Placebo in GL
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [3]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - The equality of the proportions of responders was analyzed using the CMH tests stratified by LCL baseline severity.
    Statistical analysis title
    MT10109L in LCL plus MT10109L in GL vs Placebo
    Comparison groups
    Placebo v MT10109L in LCL + MT10109L in GL
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [4]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [4] - The equality of the proportions of responders was analyzed using the CMH tests stratified by LCL baseline severity.

    Secondary: Sec Eff Endpoint 1: The Duration of LCL Treatment Effect Estimated as the Median Time to Return to Moderate or Severe LCL at Maximum Smile in Participants Who Achieved a Rating of None or Mild LCL Severity at Maximum Smile at Day 30 According to Inv Assmt

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    End point title
    Sec Eff Endpoint 1: The Duration of LCL Treatment Effect Estimated as the Median Time to Return to Moderate or Severe LCL at Maximum Smile in Participants Who Achieved a Rating of None or Mild LCL Severity at Maximum Smile at Day 30 According to Inv Assmt
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The investigator evaluates the participant's LCL severity using a 4-grade FWS scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe LCL severity at maximum smile using the FWS). FWS is a 4-grade scale (0 to 3) where 0 = none and 3 = severe.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    3
    75
    86
    Units: Days
        median (inter-quartile range (Q1-Q3))
    119 (57.0 to 186.0)
    94.0 (84.0 to 131.0)
    93.0 (85.0 to 127.0)
    No statistical analyses for this end point

    Secondary: Sec Eff Endpoint 2: The % of participants reporting mostly satisfied/very satisfied on a 5-point scale of very dissatisfied to very satisfied at Day 60 on the FLSQ follow-up version Item 5 for LCL

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    End point title
    Sec Eff Endpoint 2: The % of participants reporting mostly satisfied/very satisfied on a 5-point scale of very dissatisfied to very satisfied at Day 60 on the FLSQ follow-up version Item 5 for LCL
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The Satisfaction Question 5, grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where - 2=Very dissatisfied and 2=Very satisfied.
    End point type
    Secondary
    End point timeframe
    Day 60
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    60
    126
    134
    Units: Participants
    6
    73
    103
    No statistical analyses for this end point

    Secondary: Sec Eff Endpoint 3: The % of participants with ≥ 20-point improvement from baseline at Day 30 on the FLSQ Impact domain for LCL

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    End point title
    Sec Eff Endpoint 3: The % of participants with ≥ 20-point improvement from baseline at Day 30 on the FLSQ Impact domain for LCL
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥20-point improvement from baseline on the FLSQ impact domain (eg, reported a good improvement of the facial lines negative impact) are presented here.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    65
    130
    141
    Units: Participants
    12
    59
    77
    No statistical analyses for this end point

    Secondary: Sec Eff Endpoint 4: The % of responders for Investigator assessments of LCL severity at rest using the FWS among participants who were rated at least mild at rest at baseline, where a responder is defined as achieving ≥ 1-grade improvement from baseline

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    End point title
    Sec Eff Endpoint 4: The % of responders for Investigator assessments of LCL severity at rest using the FWS among participants who were rated at least mild at rest at baseline, where a responder is defined as achieving ≥ 1-grade improvement from baseline
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on investigator FWS rating is presented here.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    63
    126
    135
    Units: Participants
    12
    82
    91
    No statistical analyses for this end point

    Secondary: Sec Eff Endpoint 5: The % of responders for Participant assessments of LCL severity at rest using the FWS among participants who were rated at least mild at rest at baseline, where a responder is defined as achieving ≥ 1-grade improvement from baseline

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    End point title
    Sec Eff Endpoint 5: The % of responders for Participant assessments of LCL severity at rest using the FWS among participants who were rated at least mild at rest at baseline, where a responder is defined as achieving ≥ 1-grade improvement from baseline
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on participant FWS rating is presented here.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    62
    125
    136
    Units: Participants
    6
    73
    84
    No statistical analyses for this end point

    Secondary: Sec Eff Endpoint 6: The % of participants with a ≥ 20-point improvement from baseline at Day 30 on the FLO-11© questionnaire total score for LCL

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    End point title
    Sec Eff Endpoint 6: The % of participants with a ≥ 20-point improvement from baseline at Day 30 on the FLO-11© questionnaire total score for LCL
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥20-point improvement from baseline on the FLO-11 questionnaire for LCL (eg, reported less emotional and appearance-related impacts of upper-facial lines) is presented here.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    65
    131
    141
    Units: Participants
    11
    74
    98
    No statistical analyses for this end point

    Secondary: Sec Eff Endpoint 7: The % of participants with a > 4-point improvement from baseline at Day 30 on the FLO-11 questionnaire Item 2 for LCL

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    End point title
    Sec Eff Endpoint 7: The % of participants with a > 4-point improvement from baseline at Day 30 on the FLO-11 questionnaire Item 2 for LCL
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥4-point improvement from baseline on the FLO-11 questionnaire item 2 for LCL (eg, reported good improvement in the appearance of skin age) is presented here.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    65
    131
    140
    Units: Participants
    9
    60
    86
    No statistical analyses for this end point

    Secondary: Sec Eff Endpoint 8: The % of participants with a > 4-point improvement from baseline at Day 30 on the FLO-11 questionnaire Item 5 for LCL

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    End point title
    Sec Eff Endpoint 8: The % of participants with a > 4-point improvement from baseline at Day 30 on the FLO-11 questionnaire Item 5 for LCL
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥4-point improvement from baseline on the FLO-11 questionnaire item 5 for LCL (eg, reported good improvement in attractiveness) is presented here.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    61
    131
    138
    Units: Participants
    6
    58
    71
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 1a: Mean Change From Baseline in Systolic Blood Pressure (BP)

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    End point title
    Sec Safety Endpoint 1a: Mean Change From Baseline in Systolic Blood Pressure (BP)
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    Change from baseline to study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    73
    149
    157
    Units: mmHg
        arithmetic mean (standard deviation)
    1.0 ( 11.6 )
    -0.4 ( 12.29 )
    -0.3 ( 13.67 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 1b: Mean Change From Baseline in Diastolic Blood Pressure (BP)

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    End point title
    Sec Safety Endpoint 1b: Mean Change From Baseline in Diastolic Blood Pressure (BP)
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    From Baseline to study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    73
    149
    157
    Units: mmHg
        arithmetic mean (standard deviation)
    -1.2 ( 8.61 )
    -1.4 ( 8.34 )
    -0.7 ( 9.28 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 2: Mean Change From Baseline in Pulse Rate

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    End point title
    Sec Safety Endpoint 2: Mean Change From Baseline in Pulse Rate
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    Change from baseline to study exit at study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    73
    149
    157
    Units: beats/min
        arithmetic mean (standard deviation)
    -0.7 ( 11.2 )
    0.9 ( 10.54 )
    -0.4 ( 11.34 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 3: Mean Change From Baseline in Respiratory Rate

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    End point title
    Sec Safety Endpoint 3: Mean Change From Baseline in Respiratory Rate
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    Change from baseline to study exit at study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    73
    149
    157
    Units: breaths/min
        arithmetic mean (standard deviation)
    -0.4 ( 2.03 )
    -0.3 ( 2.04 )
    -0.6 ( 2.47 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 4: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate

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    End point title
    Sec Safety Endpoint 4: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    Change from baseline to study exit at day study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    72
    149
    157
    Units: beats/min
        arithmetic mean (standard deviation)
    3.3 ( 10.34 )
    4.2 ( 9.35 )
    2.7 ( 8.34 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 5: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval

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    End point title
    Sec Safety Endpoint 5: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    Change from baseline to study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    71
    149
    157
    Units: milliseconds
        arithmetic mean (standard deviation)
    -0.5 ( 9.36 )
    -0.7 ( 12.37 )
    0.0 ( 11.09 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 6: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration

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    End point title
    Sec Safety Endpoint 6: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    Change from baseline to study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    72
    149
    157
    Units: milliseconds
        arithmetic mean (standard deviation)
    0.0 ( 6.16 )
    0.4 ( 5.35 )
    1.6 ( 8.06 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 7: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval

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    End point title
    Sec Safety Endpoint 7: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    Change from baseline to study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    72
    149
    157
    Units: milliseconds
        arithmetic mean (standard deviation)
    -8.6 ( 25.07 )
    -10.4 ( 21.96 )
    -9.2 ( 21.26 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 8: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval

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    End point title
    Sec Safety Endpoint 8: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    Change from baseline to study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    72
    149
    157
    Units: milliseconds
        arithmetic mean (standard deviation)
    0.9 ( 17.34 )
    1.6 ( 16.64 )
    -1.5 ( 16.3 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 9: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval

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    End point title
    Sec Safety Endpoint 9: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    Change from baseline to study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    72
    149
    157
    Units: milliseconds
        arithmetic mean (standard deviation)
    -2.4 ( 14.21 )
    -2.7 ( 13.57 )
    -4.2 ( 13.65 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 10: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval

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    End point title
    Sec Safety Endpoint 10: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
    End point description
    Change from baseline at study exit. All safety analyses were carried out using Safety Population which includes all subjects who received at least 1 study treatment injection.
    End point type
    Secondary
    End point timeframe
    Change from baseline to study exit
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    72
    149
    157
    Units: milliseconds
        arithmetic mean (standard deviation)
    -42.6 ( 137.27 )
    -53.0 ( 120.85 )
    -35.0 ( 114.66 )
    No statistical analyses for this end point

    Secondary: Sec Safety Endpoint 11: Number of Participants With Binding and Neutralizing Antibodies

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    End point title
    Sec Safety Endpoint 11: Number of Participants With Binding and Neutralizing Antibodies
    End point description
    Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.
    End point type
    Secondary
    End point timeframe
    On Day 360
    End point values
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Number of subjects analysed
    72
    145
    150
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)that started or worsened after the first dose
    Adverse event reporting additional description
    Treatment-Emergent Adverse Events (TEAEs)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo in both Lateral Canthal Lines (LCL) and Glabellar Lines (GL) areas

    Reporting group title
    MT10109L in LCL + Placebo in GL
    Reporting group description
    MT10109L was injected into the LCL and Placebo into the GL

    Reporting group title
    MT10109L in LCL + MT10109L in GL
    Reporting group description
    MT10109L was injected into the LCL and MT10109L into the GL

    Serious adverse events
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 86 (4.65%)
    11 / 171 (6.43%)
    5 / 168 (2.98%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 86 (1.16%)
    3 / 171 (1.75%)
    2 / 168 (1.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 171 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 171 (0.58%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 171 (0.58%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 171 (0.58%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Face injury
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 171 (0.58%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Aortic valve incompetence
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 171 (0.58%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced [F]
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 171 (0.58%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 171 (0.58%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 171 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 171 (0.58%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 171 (0.58%)
    0 / 168 (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
    Colitis microscopic
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 171 (0.00%)
    0 / 168 (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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 171 (0.00%)
    0 / 168 (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
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 171 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 171 (1.17%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 171 (0.58%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Placebo MT10109L in LCL + Placebo in GL MT10109L in LCL + MT10109L in GL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 86 (39.53%)
    60 / 171 (35.09%)
    74 / 168 (44.05%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 86 (3.49%)
    9 / 171 (5.26%)
    22 / 168 (13.10%)
         occurrences all number
    3
    9
    22
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    8 / 86 (9.30%)
    15 / 171 (8.77%)
    15 / 168 (8.93%)
         occurrences all number
    8
    15
    15
    Injection site bruising
         subjects affected / exposed
    6 / 86 (6.98%)
    7 / 171 (4.09%)
    6 / 168 (3.57%)
         occurrences all number
    6
    7
    6
    Gastrointestinal disorders
    Injection site haemorrhage
         subjects affected / exposed
    6 / 86 (6.98%)
    9 / 171 (5.26%)
    6 / 168 (3.57%)
         occurrences all number
    6
    9
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 86 (6.98%)
    16 / 171 (9.36%)
    15 / 168 (8.93%)
         occurrences all number
    6
    16
    15
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 86 (5.81%)
    4 / 171 (2.34%)
    10 / 168 (5.95%)
         occurrences all number
    5
    4
    10

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Mar 2019
    Substantial, made to integrate feedback and recommendations from health authorities and improve clarity of study processes: • Clarified the primary objective and endpoint, added secondary objectives and efficacy and safety endpoints. • Added vital sign measurements, ECG assessments, and collection of blood samples for hematology and chemistry testing for Days 30 and 120. Vital sign measurements were added for 30 days after each retreatment; ECG assessments were added for the days of Retreatments 1 and 2 and 30 days after each retreatment. • Added text to clarify that collection of AEs at follow-up visits only applied to participants who received study intervention, added a new section related to which type of AESI were selected for this study, revised the timeframe for which to report nonserious AESIs, revised the duration after which an AE would not be counted as a TEAE, and added a paragraph describing analysis of TEAEs related to PDSOT and monitoring of PDSOT. • Revised the description of which pregnancy outcomes were considered SAEs. • Added statement in primary analyses describing the condition under which MT10109L 44 U was to be tested, added text describing imputation methods, replaced site with baseline LCL severity at maximum smile as assessed by the clinician (investigator or subinvestigator) as stratification factors, added text to describe the methods of sensitivity analyses, provided details on the ranking order for hierarchical testing of MT10109L 24 U and MT10109L 44 U versus placebo for secondary analyses.

    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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