Crisugabalin for Radiotherapy-Related Neuropathic Pain

Официальное название

Crisugabalin Versus Pregabalin for Radiotherapy-Related Neuropathic Pain in Head and Neck Cancers: A Multicenter, Randomized, Open-Label, Non-Inferiority Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Crisugabalin
  Days 1-14: Crisugabalin 40 mg/day, 20 mg twice daily, orally. Days 15-21: Increase dose to 80 mg/day, 40 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period. Days 22-28: Increase dose to 120 mg/day, 60 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period.
• Препарат Pregabalin
  Days 1-7: Pregabalin 150 mg/day, 75 mg twice daily, orally. Days 8-14: Increase dose to 300 mg/day, 150 mg twice daily. Days 15-21: Increase dose to 450 mg/day, 225 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period. Days 22-28: Increase dose to 600 mg/day, 300 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period.

Первичные конечные точки

• Numeric Rating Scale (NRS) Change [Срок оценки: 4 weeks]

Вторичные конечные точки (8)

• Numeric Rating Scale (NRS) Change [Срок оценки: 1 week]
• Visual Analogue Scale (VAS) Change [Срок оценки: 4 weeks]
• Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) scores [Срок оценки: 4 weeks]
• Daily Sleep Interference Scale (DSIS) [Срок оценки: 4 weeks]
• Health Status According to EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L) [Срок оценки: 4 weeks]
• Response Rates [Срок оценки: 4 weeks]
• Short-Form McGill Pain Questionnaire (SF-MPQ) [Срок оценки: 4 weeks]
• Patient Global Impression of Change (PGIC) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 11 центров

• Fujian Cancer Hospital — Фучжоу
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Affillated Cancer Hospital and Institute of Guangzhou Medical University — Гуанчжоу
• The Affiliated Brain Hospital, Guangzhou Medical University — Гуанчжоу
• Zhongshan People's Hospital — Zhongshan
• The First Affiliated Hospital of Guangxi Medical University — Nanning
• Henan Cancer Hospital (Affiliated Cancer Hospital of ZhengzhouUniversity) — Чжэнчжоу
• … и ещё 3 центра

Идентификаторы

NCT: NCT06766916 · SYSKY-2024-1020-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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