The Analgesic Efficacy and Safety of Oral Medications (Crisugabalin) in Patients With Herpes Zoster
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days at maximum tolerated dose.
研究概览
简要总结
Herpes zoster (HZ) is characterized by a painful dermatomal rash and significantly affects quality of life, with acute pain increasing the risk of postherpetic neuralgia. Although early antiviral therapy limits viral replication, its analgesic effect is insufficient, and many patients experience inadequate relief despite stepwise use of non-opioids and opioids. Gabapentinoids such as gabapentin and pregabalin are recommended adjuncts, but their efficacy in acute HZ is inconsistent and often accompanied by adverse effects that limit tolerability. Crisugabalin, a newer gabapentinoid approved for peripheral neuropathic pain, has higher affinity and slower dissociation from the α2δ-1 subunit, suggesting stronger analgesia with fewer central side effects. However, its role in managing acute HZ pain remains unknown. We therefore hypothesize that adding crisugabalin to conventional therapy will provide superior pain relief compared with standard treatment alone, and propose a prospective, randomized, controlled, open-label, blinded-endpoint trial to evaluate this.
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
- None
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
- •1. Ages more than 18 years;
- •2. Patients with onset of HZ rash less than 90 days;
- •3. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain);
- •4. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
- •5. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
- •6. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.
排除标准
- •1. History of taking gabapentin or pregabalin;
- •2. Patients with evidence of cutaneous or visceral dissemination of HZ infection (cutaneous dissemination is defined as more than 20 discrete lesions outside adjacent dermatomes) or ocular involvement of HZ;
- •3. History of intolerance or hypersensitivity to any active components or excipient of the crisugabalin;
- •4. History of systemic immune diseases, organ transplantation, or cancers;
- •5. Pregnancy or breastfeeding.
研究组 & 干预措施
Crisugabalin combined with conventional therapy group
干预措施: Crisugabalin combined conventional therapy (Drug)
Conventional therapy group
干预措施: Conventional therapy (Drug)
结局指标
主要结局
the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days at maximum tolerated dose.
时间窗: At maximum tolerated dose
The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.
次要结局
- Proportion of Patients Achieving Pain Reduction(at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication)
- The 12-item Short-Form Health Survey (SF-12) score(at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication)
- The Medical Outcomes Study Sleep Scale (MOS)(at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication)
- Adverse events(Through study completion, an average of 8 weeks)
- The worst numeric rating scale score(at 1 week, 2 weeks, 4 weeks, and 8 weeks after experimental drug medication)
研究者
Fang Luo
Director, Department of Pain Management, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital