Crisugabalin Versus Pregabalin for Radiotherapy-Related Neuropathic Pain in Head and Neck Cancers: A Multicenter, Randomized, Open-Label, Non-Inferiority Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 11
- 主要终点
- Numeric Rating Scale (NRS) Change
研究概览
简要总结
The purpose of this study is to evaluate whether Crisugabalin has similar efficacy compared to Pregabalin in reducing radiotherapy-related neuropathic pain (RRNP) in patients with head and neck cancers.
详细描述
The primary objective of this study is to determine whether Crisugabalin provides non-inferior pain relief compared to Pregabalin in patients with head and neck cancer experiencing radiotherapy-related neuropathic pain. The trial adopts a multicenter, randomized, open-label design, and the primary endpoint is the change in Numeric Rating Scale (NRS) pain scores from baseline to 4 weeks. The study aims to provide new evidence to support treatment strategies for this condition, which significantly affects patients' quality of life.
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
- •Ability to understand and voluntarily sign a written informed consent form.
- •Male or female patients aged ≥18 years with an expected survival of at least 5 months.
- •Histologically confirmed head and neck tumors treated with radiotherapy at least 6 months prior to screening.
- •Average NRS pain score ≥4 over 7 days during the screening period, with pain localized to nerve-innervated areas corresponding to the radiotherapy site, such as the head, face, neck, and arms.
- •Diagnosis of neuropathic pain persisting for at least 4 weeks, confirmed by two trained neurologists based on clinical history, symptoms, signs, and a Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score ≥12 (Chinese version).
- •Adequate cognitive and language abilities to communicate and complete study questionnaires.
排除标准
- •Severe abnormalities in hematological, hepatic, or renal function, as evidenced by:
- •Hematology: Neutrophil count <1.5×10⁹/L, platelet count <90×10⁹/L, or hemoglobin <100 g/L.
- •Liver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3× upper limit of normal (ULN), or total bilirubin (TBIL) >1.5× ULN.
- •Renal function: Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² or undergoing dialysis.
- •Creatine kinase >2× ULN.
- •Chronic systemic diseases that may interfere with study participation, including but not limited to:
- •Severe cardiopulmonary diseases such as unstable angina, myocardial infarction, severe arrhythmia, WHO functional classification III-IV heart failure, uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP >100 mmHg), or recurrent asthma.
- •Chronic gastrointestinal diseases, such as liver fibrosis, recurrent indigestion or diarrhea, or peptic ulcers.
- •Neurological or psychiatric conditions affecting pain assessment, including epilepsy, recurrent dizziness, headache, memory, or cognitive disorders; cerebrovascular accidents or transient ischemic attacks within 6 months of screening.
- •Known allergy to study drugs or chemically related compounds.
- •Current diagnosis of tumor recurrence or metastasis associated with tumor-related pain.
- •Neuropathic pain not caused by radiotherapy, such as postherpetic neuralgia, diabetic neuropathy, HIV-related neuropathy, spinal cord injury, or other neurological diseases.
- •Use of pregabalin/crisugabalin within 4 weeks before screening.
- •Pregnant, planning to become pregnant during the study, or breastfeeding. Participants and their partners unwilling to use reliable contraception (e.g., condoms, spermicides, intrauterine devices) from the time of consent until 28 days after the last dose of study medication.
- •Participation in any other clinical trial within 30 days prior to screening.
- •Any other condition deemed unsuitable for study participation by the investigator.
- •Use of prohibited medications within at least 5 half-lives of the drug before screening, with prohibition maintained throughout the study.
- •Previous use of pregabalin ≥300 mg/day or gabapentin ≥1200 mg/day deemed ineffective.
研究组 & 干预措施
Crisugabalin
The initial dose is one Crisugabalin capsule (20 mg) taken twice daily. The dose will be gradually increased to the maximum tolerated dose or the maximum daily dose of three capsules (60 mg) taken twice daily.
干预措施: Crisugabalin (Drug)
Pregabalin
The initial dose is one capsule of Pregabalin (75 mg) taken twice daily. The dose will be gradually increased to the maximum tolerated dose or the maximum daily dose of four capsules (300 mg) taken twice daily.
干预措施: Pregabalin (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS) Change
时间窗: 4 weeks
The change in NRS score from baseline to Week 4 of treatment. The NRS measures pain intensity on a scale of 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
次要结局
- Patient Global Impression of Change (PGIC)(4 weeks)
- Numeric Rating Scale (NRS) Change(1 week)
- Visual Analogue Scale (VAS) Change(4 weeks)
- Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) scores(4 weeks)
- Daily Sleep Interference Scale (DSIS)(4 weeks)
- Health Status According to EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L)(4 weeks)
- Response Rates(4 weeks)
- Short-Form McGill Pain Questionnaire (SF-MPQ)(4 weeks)
研究者
Yamei Tang
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University