MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)

Study Overview
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Brief Summary
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To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.

Official Title
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A Multicenter, Long-term, Open-label Study to Evaluate the Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines and Lateral Canthal Lines

Conditions
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Glabellar Lines, Lateral Canthal Lines

Intervention / Treatment
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* Drug: MT10109L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completion of lead-in Phase 3 study; Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Exclusion Criteria: Known immunization or hypersensitivity to any botulinum toxin serotype; Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function; Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures; Females who are pregnant, nursing, or planning a pregnancy during the study; Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT10109L Dose 1<br>MT10109L Dose 1 will be injected into the GL. | Drug: MT10109L<br>* MT10109L will be injected into either the GL, LCL, or both the LCL and GL.<br>|
| Experimental: MT10109L Dose 2<br>MT10109L Dose 2 will be injected into the LCL. | Drug: MT10109L<br>* MT10109L will be injected into either the GL, LCL, or both the LCL and GL.<br>|
| Experimental: MT10109L Dose 1 + Dose 2<br>MT10109L Dose 1 will be injected into the GL and MT10109L Dose 2 will be injected into the LCL. | Drug: MT10109L<br>* MT10109L will be injected into either the GL, LCL, or both the LCL and GL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experienced an adverse event |  | Baseline to Day 720 | 
| Mean change from baseline in pulse rate (beats per minute) |  | Baseline to Day 720 | 
| Mean change from baseline in blood pressure (mm Hg) |  | Baseline to Day 720 | 
| Mean change from baseline in respiratory rate (breaths per minute) |  | Baseline to Day 720 | 
| Number of participants with binding and neutralizing antibodies |  | Baseline to Day 720 |