2024-514689-38-01招募中2 期
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 Painful Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 9
- 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
• To evaluate the efficacy of VX-993 doses in treating subjects with pain associated with diabetic peripheral neuropathy (DPN) • To evaluate the safety and tolerability of VX-993
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus type 1 or type 2 with o glycosylated hemoglobin A1c (HbA1c) ≤9%; o in the opinion of the investigator, optimized glycemic control, and subject has been stable on anti-diabetic medicine/drugs or dietary treatment for ≥3 months before Screening Visit 1; and o 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, such as post-herpetic neuralgia, post-traumatic nerve injury, diabetic amyotrophy, human immunodeficiency virus (HIV) neuropathy, immune sensory and autonomic polyneuropathy (e.g., Sjogren’s syndrome), hereditary sensory and autonomic polyneuropathy, focal diabetic neuropathies (e.g., proximal motor neuropathy, mononeuropathy, mononeuropathy multiplex), or chronic regional pain syndrome. Previously diagnosed compressive neuropathy (e.g., carpal tunnel syndrome) with symptoms limited to upper extremities that is now resolved is not exclusionary
- •Cardiac dysrhythmias requiring anti-arrhythmic treatment(s) within the last 2 years; history or evidence of abnormal study ECGs that in the opinion of the investigator or medical monitor would preclude the subject’s participation in the study; or history of QT prolongation or standard 12-lead ECG (performed in triplicate) demonstrating median QTcF >450 msec at Screening Visit 1; or clinical evidence of structural heart disease.
- •History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months before Screening Visit 1.
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
Change from baseline in the weekly average of daily pain intensity on the numeric pain rating scale (NPRS) at Week 12
次要结局
- Proportions of subjects with ≥30%, ≥50%, and ≥70% reductions from baseline in the weekly average of daily pain intensity on the NPRS at Week 12
- Safety and tolerability based on adverse events (AEs), laboratory test results, vital signs, and ECGs
研究者
Clinical Trials and Medical Info
Scientific
Vertex Pharmaceuticals Inc.
研究点 (9)
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