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OpenTrials
Completed

NCT Number: NCT04157686

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

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.

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Key information

Conditions

Glabellar Lines Lateral Canthal Lines

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UZ Brussel, Jette, Brussels Capital, Belgium

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About this study

Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006 (NCT03732833) (referred to as Lead-In studies). The objective is to evaluate long term safety of MT10109L. Participants will include those who completed the global lead-in studies and meet the eligibility criteria for entering this open-label extension study.

Participants who meet retreatment criteria will receive MT10109L administered in the same treatment area(s) with the same number of injections and injection sites as in their lead-in studies.

The safety and efficacy data from the lead-in and this open-label extension will be summarized.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MT10109L Dose 1

Drug

MT10109L Dose 1 will be injected into the GL area

MT10109L Dose 2

Drug

MT10109L Dose 2 will be injected into the LCL area

MT10109L Dose 1 + Dose 2

Drug

MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area

Primary outcomes

  1. Number of Participants Who Experienced Any Adverse Event (AE)

    Time frame: Baseline to Day 720 or Study Exit

    The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit.

  2. Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)

    Time frame: Baseline to Day 720 or Study exit

    This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study.

  3. Mean Change From Baseline in Pulse Rate (Beats Per Minute)

    Time frame: Baseline to Day 720 or Study Exit

    The outcome reported here is the mean change in pulse rate from baseline to study exit.

  4. Mean Change From Baseline in Systolic Blood Pressure (mm Hg)

    Time frame: Baseline to Day 720 or Study Exit

    The outcome reported here is the mean change in Systolic BP from baseline to study exit.

  5. Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)

    Time frame: Baseline to Day 720 or Study Exit

    The outcome reported here is the mean change in Diastolic BP from baseline to study exit.

  6. Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)

    Time frame: Baseline to Day 720 or Study Exit

    The outcome reported here is the mean change in respiratory rate from baseline to study exit.

  7. Number of Participants With Binding and Neutralizing Antibodies

    Time frame: Baseline to Day 720 or Study Exit

    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.

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2019
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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