A Phase I, Randomised, Double-blind, Parallel-group, Single-centre Comparative Study to Evaluate the Pharmacodynamic Profile of Dysport®, Botox®, and Xeomin® in the Extensor Digitorum Brevis (EDB) Model in Healthy Adult Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28
研究概览
简要总结
Study aimed at comparing the pharmacodynamic profile (including duration of action) of three commercialized toxins by measuring the action potential of the injected muscle (extensor digitorum brevis)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participant must be between18 to 65 years of age inclusive, at the time of signing the informed consent
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring
- •A body mass index (BMI) within the range 18 and 30 kg/m2 (inclusive).
排除标准
- •Any medical condition that may put the participant at risk with exposure to BoNT, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function
- •Previous treatment with botulinum toxin (BoNT) (any serotype) during the past 6 months
- •Known hypersensitivity to any of the components of the Dysport/ Botox/ Xeomin formulation (which includes human serum albumin, lactose, sucrose) or allergy to cow's milk protein
- •Use of agents that could interfere with neuromuscular transmission, including calcium channel blockers, penicillamine, aminoglycosides, lincosamides, polymixins, magnesium sulphate, anticholinesterases, succinylcholine and quinidine
研究组 & 干预措施
Dysport®
40 Units (U) Intramuscular (IM) injection at day 1.
干预措施: Botulinum toxin type A (Biological)
Botox®
16U IM at day 1.
干预措施: Botulinum toxin type A (Biological)
Xeomin®
16U IM at day 1.
干预措施: Botulinum toxin type A (Biological)
结局指标
主要结局
Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28
时间窗: Baseline (Day 1) and Week 28
The CMAP procedure was performed on the injected foot by a neurophysiologist. Percentage relative to baseline was calculated as (value at Week 28 \[mean of the 3 measurements\]/baseline value) multiplied by (\*) 100. The adjusted mean was obtained from a mixed-effects model for repeated measures (MMRM) model with Fisher scoring. Baseline was defined as the last non-missing measurement taken prior to study drug administration. Baseline value used for this analysis was the average of 6 measurements, the 3 measurements at screening and the 3 measurements at baseline.
次要结局
- Change From Baseline in AM % of CMAP Total Amplitude at Week 40(Baseline (Day 1) and Week 40)
- Percentage of Participants With Recovery of CMAP Total Amplitude(At Weeks 28 and 40)
- Number of Participants Who Achieved Maximal Effect of CMAP Total Amplitude(At Weeks 1, 4, 8 and 20)
- Time to Onset of Action of Study Intervention(From Baseline (Day 1) up to Week 40)
- Percentage of Maximal Inhibition (Maximal Effect) of CMAP Total Amplitude(Up to Week 40)
- Duration of Response(From Baseline (Day 1) up to Week 40)