A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 50
- 主要终点
- Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful 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) ≤9%; and
- •Presence of bilateral pain in lower extremities due to DPN 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 received Pregabalin 100 mg 3 times per day (tid) for 12 weeks
干预措施: Pregabalin (Drug)
Pregabalin
Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks
干预措施: Placebo (matched to SUZ) (Drug)
Suzetrigine (SUZ): Low Dose
Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks.
干预措施: Suzetrigine (Drug)
Suzetrigine (SUZ): Low Dose
Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks.
干预措施: Placebo (matched to pregabalin) (Drug)
Suzetrigine (SUZ): Mid Dose
Participants received SUZ 46 mg tablet qd for 12 weeks.
干预措施: Suzetrigine (Drug)
Suzetrigine (SUZ): Mid Dose
Participants received SUZ 46 mg tablet qd for 12 weeks.
干预措施: Placebo (matched to pregabalin) (Drug)
Suzetrigine (SUZ): High Dose
Participants received SUZ 69 mg tablet qd for 12 weeks.
干预措施: Suzetrigine (Drug)
Suzetrigine (SUZ): High Dose
Participants received SUZ 69 mg tablet qd for 12 weeks.
干预措施: Placebo (matched to pregabalin) (Drug)
结局指标
主要结局
Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)
时间窗: Baseline, At Week 12
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
次要结局
- Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score(Baseline, At Week 12)
- Percentage of Participants With Greater Than or Equal to (≥) 30 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS(Baseline, At Week 12)
- Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS(Baseline, At Week 12)
- Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS(Baseline, At Week 12)
- Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment(Baseline, At Week 12)
- Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Day 1 up to Week 14)