A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia (PHN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 24
- 主要终点
- Change from baseline to the last week of treatment in daily pain scores
研究概览
简要总结
The purpose of this study is to investigate whether NXN-462, a selective nNOS inhibitor, is effective in reducing pain levels in patients with post-herpetic neuralgia.
详细描述
NXN-462 is designed to target the nitric oxide synthase system (NOS), specifically the neuronal NOS (nNOS) isoform. By design, NXN-462 is a potent inhibitor of nNOS with good affinity, and has little or no affinity for a range of G protein-coupled receptors, ion channels, and enzymes. NXN-462 is being developed as an oral therapy for the treatment of neuropathic pain syndromes, including PHN. This drug design strategy provides a new therapeutic paradigm for the treatment of chronic neuropathic pain.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male, or a non-pregnant, non-lactating female 18 years or older
- •Have voluntarily provided written informed consent
- •able to speak, read, write, and understand English
- •clinical diagnosis of PHN for a minimum of 6 months
- •pain intensity score of ≥3 on a 0-10 Numerical Rating Scale (NRS) at the Screening Visit
- •generally in good health (other than PHN) at Screening
排除标准
- •Are pregnant and/or lactating
- •Diagnosis of any chronic pain syndrome that would interfere with the assessment of PHN
- •evidence of multiple causes of neuropathic pain,e.g.lumbar radiculopathy in the lumbosacral area
- •Have had neuroablation or neurosurgical intervention for PHN
- •Have been taking opioid analgesics for >5 days/week
- •Have received nerve block or intrathecal analgesia within 6 weeks of the study
- •History of significant gastrointestinal disease, liver disease, renal disease, endocrine disease, or cardiovascular disease
- •clinically significant abnormal clinical laboratory test results or vital signs
- •Are immunocompromised or immunosuppressed for any reason
- •History of alcohol or other substance abuse (not including nicotine or tobacco) within 5 years
- •Significant psychiatric disorder which requires drug treatment (except depression or anxiety treated with Selective Serotonin Re-uptake Inhibitors)
- •Have received an investigational drug or have used an investigational device within 30 days of Screening.
- •Have previously been randomized to this study
研究组 & 干预措施
NXN-462
capsule, 200 mg, bi.d. 28-days
干预措施: NXN-462 (Drug)
Placebo
capsule, b.i.d. 28-days
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to the last week of treatment in daily pain scores
时间窗: 4 weeks
Change from baseline to the last week of treatment in daily (24-hour recall) pain scores comparing NXN-462 with placebo
次要结局
- percentage of responders(four weeks)
- Percentage of subjects with moderate or much improvement at the end of the Treatment Period, according to Patient Global Impression of Change(four weeks)
- average weekly change in pain score from baseline to the end of the Treatment Period(four weeks)
- Adverse events (AEs), vital signs, and clinical laboratory tests(six weeks)
- Analysis of percent change from baseline in daily pain score(four weeks)
- Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score(four weeks)
- Rescue medication consumption(four weeks)
- Change from baseline to the end of the Treatment Period in Modified Brief Pain Inventory Short Form score, pain interference subscale(four weeks)