Phase 3
N=957
MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
Glabellar Lines · Lateral Canthal Lines
Bottom Line
View on ClinicalTrials.gov: NCT04157686 ↗Enrolled (actual)
957
Serious AEs
6.7%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants Who Experienced Any Adverse Event (AE) — 39; 39; 80; 89 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MT10109L Dose 1 (Drug); MT10109L Dose 2 (Drug); MT10109L Dose 1 + Dose 2 (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Medy-Tox
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Any Adverse Event (AE) |
39; 39; 80; 89; 74; 80 | — |
| PRIMARY Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) |
18; 4; 31; 34; 11; 22 | — |
| PRIMARY Mean Change From Baseline in Pulse Rate (Beats Per Minute) |
3.2; -2.2; -1.2; 2.0; 0.6; 0.7 | — |
| PRIMARY Mean Change From Baseline in Systolic Blood Pressure (mm Hg) |
1.4; -1.9; 1.9; 0.6; 1.1; 1.8 | — |
| PRIMARY Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) |
1.1; -0.6; 1.3; 1.5; 0.7; 0.0 | — |
| PRIMARY Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) |
0.3; 0.6; -0.5; 0.2; 0.5; -0.4 | — |
| PRIMARY Number of Participants With Binding and Neutralizing Antibodies |
0; 0; 0; 0; 2; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04157686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.