NCT06176196已完成2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Lumbosacral Radiculopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 54
- 主要终点
- Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight greater than or equal to (>=)45 kilogram (kg)
- •Body mass index (BMI) less than or equal to (<=) 40 kg/ meter square (m^2)
- •Diagnosis of PLSR for greater than (>)3 months as per criteria pre-specified in the protocol
- •Weekly average of daily NPRS score >=4 and <10 with limited variation in the 7-day Run-in Period
排除标准
- •More than 3 missing daily NPRS scores during the 7-day Run-in Period
- •Moderate or severe painful neuropathy other than PLSR as pre-specified in the protocol
- •History of prior lumbar spine surgery (e.g., discectomies, laminectomies, foraminotomies, or fusion)
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
VX-548
Experimental
Participants will receive VX-548 up to 12 weeks.
干预措施: VX-548 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matched to VX-548 up to 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)
时间窗: Baseline, Week 12
次要结局
- Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)(Baseline, Week 12)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Week 14)
研究者
研究点 (54)
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