A Randomised, Double-Blind, Placebo-Controlled, Dose-Response Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weekly Average of Average Daily Pain Score to Week 12
研究概览
简要总结
This is a study investigating the effect of MEDI7352 on chronic pain in patients with painful diabetic neuropathy.
The study incudes a screening period of up to 45 days and a 12-week treatment period during which MEDI7352 or placebo will be administered intravenously (IV) on 6 occasions, with each dose separated by 14 days. There will be a 6-week follow-up period.
Subjects will randomly be assigned to double-blind treatment with one of 4 dose levels of MEDI7352 or placebo
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)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MEDI7352 High Dose
Participants received 6 doses of IV MEDl7352 high dose during 12-week treatment period.
干预措施: MEDI7352 (Drug)
Placebo
Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.
干预措施: Placebo (Other)
MEDl7352 Low Dose
Participants received 6 doses of IV MEDl7352 low dose during 12-week treatment period.
干预措施: MEDI7352 (Drug)
MEDl7352 Medium Dose
Participants received 6 doses of IV MEDl7352 medium dose during 12-week treatment period.
干预措施: MEDI7352 (Drug)
结局指标
主要结局
Change From Baseline in Weekly Average of Average Daily Pain Score to Week 12
时间窗: Baseline (Day -7 to Day -1, inclusive) through Week 12
Change from baseline to Week 12 in weekly average of average daily pain score is reported. Participants assessed their perceived daily average neuropathic pain over the previous 24 hours using an 11-point numerical rating scale (NRS), with 0 representing no pain and 10 representing the worst pain imaginable. Participants were instructed to assess their average daily pain at approximately the same time every morning, and to record the response in a subject diary (electronic patient-reported outcome \[ePRO\]).
次要结局
- Change From Baseline in Weekly Average of Average Daily Pain Score(Baseline (Day -7 to Day -1, inclusive), Weeks 2, 4, 6, 8, 10, and 18)
- Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Average Daily Pain Score(Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up))
- Change From Baseline in Galer Neuropathic Pain Scale (NPS)(Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up))
- Change From Baseline in Daily Sleep Interference Scale (DSIS)(Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up))
- Percentage of Participants With 'Improved', 'Much Improved', or 'Very Much Improved' Status in Patient Global Impression of Change (PGIC)(Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up))
- Change From Baseline in 36-item Short-Form Health Survey (SF-36)(Baseline (Day -7 to Day -1, inclusive) and Week 12)
- Percentage of Participants Taking Any Rescue Medication(Baseline (Day -7 to Day -1, inclusive) through Week 12)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(Day 1 through 20.42 weeks (maximum observed duration))
- Number of Participants With Abnormal Vital Signs Reported as TEAEs(Day 1 through 20.42 weeks (maximum observed duration))
- Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs)(Day 1 through 20.42 weeks (maximum observed duration))
- Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs(Day 1 through 20.42 weeks (maximum observed duration))
- Number of Participants With Clinically Significant Findings in Physical Examination Reported as TEAEs(Day 1 through 20.42 weeks (maximum observed duration))
- Number of Participants With Clinically Significant Findings in Neurological Examination(Day 1 through 20.42 weeks (maximum observed duration))
- Number of Participants With Abnormal Dorsiflexion Strength(Day 1 through 20.42 weeks (maximum observed duration))
- Number of Participants With Abnormal Deep Tendon Reflex (Knee and Ankle)(Day 1 through 20.42 weeks (maximum observed duration))
- Change From Baseline in Total Neuropathy Score-Nurse (TNSn)(Baseline (Day -45 to -1), pre-dose on Day 1, Weeks 2, 4, 6, 8, 10, 12, and 18/early termination)
- Number of Participants With Investigator Reported Significant Changes From Baseline in Motor and Sensory Nerve Conduction(Day 1 through 20.42 weeks (maximum observed duration))
- Number of Participants With at Least One Concomitant Medication(Day 1 through 20.42 weeks (maximum observed duration))
- Number of Participants With Injection Site Reaction(Day 1 through 20.42 weeks (maximum observed duration))
- Number of Participants With Infusion Reaction(Day 1 through 20.42 weeks (maximum observed duration))
- Serum Total Nerve Growth Factor (NGF) Concentrations(Day 1 (pre-dose; baseline), Weeks 2, 4, 6, 8, 10 (Day 70; pre-dose, immediately before end of infusion, 8 hours and 24 hours post Day 70 infusion [Day 71]), 11, and 12 (approximately same time of day as Week 10 infusion))
- Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI7352(Pre-dose at baseline (Day -45 to -1) and Study Weeks 2, 4, 8, 10, 12, and 18 (follow-up))