Crisugabalin Versus Pregabalin for Radiotherapy-Related Neuropathic Pain in Head and Neck Cancers: A Multicenter, Randomized, Open-Label, Non-Inferiority Trial
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Changsha Central Hospital
NOT_YET_RECRUITING
Changsha
Hunan Brain Hospital
NOT_YET_RECRUITING
Changsha
Hunan Provincial People's Hospital
NOT_YET_RECRUITING
Changsha
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Affillated Cancer Hospital and Institute of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
The Affiliated Brain Hospital, Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Henan Cancer Hospital (Affiliated Cancer Hospital of ZhengzhouUniversity)
NOT_YET_RECRUITING
Zhengzhou
Zhongshan People's Hospital
NOT_YET_RECRUITING
Zhongshan
Contact Information
Primary
Songhua Xiao
xiaosh@mail.sysu.edu.cn
86+13922232774
Time Frame
Start Date:2025-05-07
Estimated Completion Date:2026-12-31
Participants
Target number of participants:172
Treatments
Experimental: 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.
Active_comparator: 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.