NCT03304522已完成2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, 6-Week, Parallel-design Study of the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy
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
- 89
- 试验地点
- 34
- 主要终点
- Change in Weekly Average of Daily Pain Intensity on the 11 Point NRS
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy of VX-150 for the treatment of pain caused by small fiber neuropathy.
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
- •Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg
- •Diagnosis of small fiber neuropathy, as per European Federation Neurological Societies (EFNS)/American Academy of Neurology (AAN) guidelines, with pain for at least 3 months prior to screening
- •Reduction below the 5th percentile of sex and age-adjusted normal values in epidermal nerve fiber density on punch skin biopsy at the distal site of the leg performed at screening
- •Normal nerve conduction studies (NCS), including presence of sural response.
- •Average NRS score between ≥4 and ≤9 reported in the daily diary on Days -7 through -1
排除标准
- •History in the past 10 years of malignancy except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
- •History of connective tissue disorders, sarcoidosis, Sjögren's syndrome, amyloidosis, Fabry's disease, celiac disease, lyme disease, autoimmune disorders
- •A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
- •Current clinically significant liver or kidney dysfunction
- •Current uncontrolled thyroid dysfunction
- •A diagnosis of diabetes, HbA1C ≥8% at screening
- •History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- •Concomitant severe pain conditions which may impair self-assessment of pain due to small fiber neuropathy
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
VX-150
Experimental
干预措施: VX-150 (Drug)
结局指标
主要结局
Change in Weekly Average of Daily Pain Intensity on the 11 Point NRS
时间窗: From Baseline at Week 6
Pain intensity was evaluated using the 11-point NRS (where 0 signified no pain and 10 signified worst imaginable pain) during the last 24 hours on the NRS each evening. Higher score indicates greater level of pain.
次要结局
- Percentage of Participants With Greater Than or Equal to (>=) 30 Percent (%) Reduction in the Weekly Average of Daily Pain Intensity on the 11-Point NRS(From Baseline at Week 6)
- Change in the Daily Sleep Interference Scale (DSIS)(From Baseline at Week 6)
- Percentage of Participants With >=50% Reduction in the Weekly Average of Daily Pain Intensity on the 11-Point NRS(From Baseline at Week 6)
- Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 up to Week 10)
- Percentage of Participants Categorized as Improved on the Patient Global Impression of Change (PGIC) Scale(At Week 6)
- Change in Pain Intensity on the 11-Point NRS(From Baseline at Week 6)
- Pre-dose Plasma Concentration (Ctrough) of VRT-1207355 and the Metabolite VRT-1268114(Pre-dose at Day 7)
- Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses(Day 1 up to Week 10)
研究者
研究点 (34)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back PainModerate to Severe Acute Lower Back PainNCT05096494Scilex Pharmaceuticals, Inc.76
进行中（未招募）
2 期
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)NCT06643481Novartis Pharmaceuticals251
已完成
2 期
A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)NauseaVomitingNCT00394966Schering-Plough450
终止
2 期
Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UCUlcerative ColitisNCT02808390PPM Services S.A.19
已完成
2 期
Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative ColitisUlcerative ColitisNCT01612039Telsar Pharma Inc.112