A Phase IIa, Multi-Centre, Randomised, Double-Blind, Cross-Over, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy Incorporating an Open Label Pilot Arm
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Efficacy as measured by reduction in pain using a numerical rating scale.
研究概览
简要总结
A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male subjects and female subjects aged ≥18 years
- •Subjects who have a history of pain at least 6 months and ≤7 years attributed to diabetic peripheral neuropathy
- •A body mass index ranging from 18 to 45 kg/m2
排除标准
- •Subjects who have participated in a clinical study of any IMP (other than placebo) within 12 weeks (from last administration) prior to screening or who are currently participation in another clinical study
- •Unstable or uncontrolled diabetes
- •Clinically significant 12-lead ECG abnormalities
研究组 & 干预措施
MT-8554 low dose
Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period.
干预措施: MT-8554 low dose (Drug)
MT-8554 middle dose
Patients who meet eligibility criteria will be administered twice daily middle dose of MT-8554 during the treatment period.
干预措施: MT-8554 middle dose (Drug)
MT-8554 high dose
Patients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period.
干预措施: MT-8554 high dose (Drug)
MT-8554, then placebo
The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase
干预措施: MT-8554 low dose (Drug)
MT-8554, then placebo
The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase
干预措施: MT-8554 middle dose (Drug)
MT-8554, then placebo
The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase
干预措施: MT-8554 high dose (Drug)
MT-8554, then placebo
The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase
干预措施: Placebo (Drug)
Placebo, then MT-8554
The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase
干预措施: MT-8554 low dose (Drug)
Placebo, then MT-8554
The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase
干预措施: MT-8554 middle dose (Drug)
Placebo, then MT-8554
The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase
干预措施: MT-8554 high dose (Drug)
Placebo, then MT-8554
The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy as measured by reduction in pain using a numerical rating scale.
时间窗: Up to Day 49
Pain reduction using an 11-point numerical rating scale
Safety and Tolerability as measured by vital signs and Adverse Events
时间窗: Up to Day 22
Number of participants with potentially clinically important vital sign measurements or tolerability issues
次要结局
- Number of subjects with electrocardiogram (ECG) findings of potential clinical importance(Up to Day 49)
- Plasma concentration of MT-8554(Up to Day 49)