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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

MT10109L-006

ISRCTN number

US NCT number

NCT03732833

WHO universal trial number (UTN)

Other trial identifiers

IND Number: 121473

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

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

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?

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

Independent data monitoring committee (IDMC) involvement?

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

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

393

From 65 to 84 years

85 years and over

Subject disposition

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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.

Screening details

424 met the inclusion/exclusion criterial and were randomized.

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.

Are arms mutually exclusive

Yes

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.

MT10109L in LCL + Placebo in GL

Arm description

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.

MT10109L in LCL + MT10109L in GL

Arm description

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 title

Re-treatment 1

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

Are arms mutually exclusive

Yes

Placebo

Arm description

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.

MT10109L in LCL + Placebo in GL

Arm description

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.

MT10109L in LCL + MT10109L in GL

Arm description

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 title

Re-treatment 2

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

Are arms mutually exclusive

Yes

Placebo

Arm description

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.

MT10109L in LCL + Placebo in GL

Arm description

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.

MT10109L in LCL + MT10109L in GL

Arm description

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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Reporting group title

Placebo

Reporting group description

Reporting group title

MT10109L in LCL + Placebo in GL

Reporting group description

Reporting group title

MT10109L in LCL + MT10109L in GL

Reporting group description

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 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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Reporting group title

Placebo

Reporting group description

Reporting group title

MT10109L in LCL + Placebo in GL

Reporting group description

Reporting group title

MT10109L in LCL + MT10109L in GL

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

MT10109L in LCL + Placebo in GL

Reporting group description

Reporting group title

MT10109L in LCL + MT10109L in GL

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

MT10109L in LCL + Placebo in GL

Reporting group description

Reporting group title

MT10109L in LCL + MT10109L in GL

Reporting group description

Subject analysis set title

Demographic and other Baseline Characteristics - ITT

Subject analysis set type

Intention-to-treat

Subject analysis set description

Subject analysis set title

Demographic and other Baseline Characteristics - mITT

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

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

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.

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

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.

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

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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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 name

MedDRA

Dictionary version

23.1

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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Were there any global substantial amendments to the protocol? Yes

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.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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