A Multicenter, Long-term, Open-label Study to Evaluate the Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines and Lateral Canthal Lines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 957
- 试验地点
- 38
- 主要终点
- Number of Participants Who Experienced Any Adverse Event (AE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo/MT10109L Dose 1
The participant pool in this arm are from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continue receiving Dose 1 in the open-label MT10109L-004 study
干预措施: MT10109L Dose 1 (Drug)
Placebo/MT10109L Dose 2
The participant pool in this arm are from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continue receiving Dose 2 in the open-label MT10109L-004 study.
干预措施: MT10109L Dose 2 (Drug)
Placebo/MT10109L Dose 1 + Dose 2
The participant pool in this arm are from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
干预措施: MT10109L Dose 1 + Dose 2 (Drug)
MT10109L Dose 1/Dose 1
The participant pool in this arm are from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continue receiving Dose 1 in the open-label MT10109L-004 study.
干预措施: MT10109L Dose 1 (Drug)
MT10109L Dose 2/Dose 2
The participant pool in this arm are from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continue receiving Dose 2 in the open-label MT10109L-004 study.
干预措施: MT10109L Dose 2 (Drug)
MT10109L Dose 1/Dose 1+2
The participant pool in this arm are from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
干预措施: MT10109L Dose 1 + Dose 2 (Drug)
MT10109L Dose 2/Dose 1+2
The participant pool in this arm are from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
干预措施: MT10109L Dose 1 + Dose 2 (Drug)
MT10109L Dose 1+2/Dose 1+2
The participant pool in this arm are from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
干预措施: MT10109L Dose 1 + Dose 2 (Drug)
结局指标
主要结局
Number of Participants Who Experienced Any Adverse Event (AE)
时间窗: 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.
Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)
时间窗: 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.
Mean Change From Baseline in Systolic Blood Pressure (mm Hg)
时间窗: Baseline to Day 720 or Study Exit
The outcome reported here is the mean change in Systolic BP from baseline to study exit.
Mean Change From Baseline in Pulse Rate (Beats Per Minute)
时间窗: Baseline to Day 720 or Study Exit
The outcome reported here is the mean change in pulse rate from baseline to study exit.
Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)
时间窗: Baseline to Day 720 or Study Exit
The outcome reported here is the mean change in Diastolic BP from baseline to study exit.
Number of Participants With Binding and Neutralizing Antibodies
时间窗: 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.
Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)
时间窗: Baseline to Day 720 or Study Exit
The outcome reported here is the mean change in respiratory rate from baseline to study exit.
次要结局
未报告次要终点