A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 93
- 主要终点
- Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of diabetes mellitus type 1 or type 2 with
- •Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and
- •Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year
排除标准
- •Painful neuropathy other than DPN
- •History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- •History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Pregabalin
Participants will be randomized to receive Pregabalin.
干预措施: Pregabalin (Drug)
VX-993
Participants will be randomized to receive multiple doses of different dose levels of VX-993.
干预措施: Placebo (matched to pregabalin) (Drug)
Pregabalin
Participants will be randomized to receive Pregabalin.
干预措施: Placebo (matched to VX-993) (Drug)
VX-993
Participants will be randomized to receive multiple doses of different dose levels of VX-993.
干预措施: VX-993 (Drug)
结局指标
主要结局
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12
时间窗: From Baseline up to Week 12
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12
时间窗: From Baseline up to Week 12
次要结局
- Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12(From Baseline up to Week 12)
- Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12(From Baseline up to Week 12)
- Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12(From Baseline up to Week 12)
- Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12(From Baseline up to Week 12)
- Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12(From Baseline up to Week 12)
- Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12(From Baseline up to Week 12)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 up to Week 16)