RecruitingPhase 2NCT06766916

Crisugabalin for Radiotherapy-Related Neuropathic Pain

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


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

172 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing crisugabalin — a newer nerve pain medication — for people who develop chronic nerve pain (neuropathic pain) after receiving radiation therapy for head and neck cancer. This type of pain is common after radiotherapy and can be difficult to treat. **You may be eligible if...** - You are 18 or older and have been diagnosed with a head or neck tumor that was treated with radiation at least 6 months ago - You are experiencing pain (average score of 4 or more out of 10) in areas related to your radiation treatment, such as the head, face, neck, or arms - Your pain has been diagnosed as neuropathic (nerve pain) lasting at least 4 weeks, confirmed by two neurologists - You are expected to live at least 5 months - Your thinking and communication are clear enough to participate **You may NOT be eligible if...** - You are currently on certain other nerve pain medications that may conflict with the study drug - You have severe kidney or liver problems - You have a history of drug abuse or dependence - Your pain is not neuropathic in nature Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCrisugabalin

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.

DRUGPregabalin

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.


Locations(11)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Affillated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

The Affiliated Brain Hospital, Guangzhou Medical University

Guangzhou, Guangdong, China

Zhongshan People's Hospital

Zhongshan, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Henan Cancer Hospital (Affiliated Cancer Hospital of ZhengzhouUniversity)

Zhengzhou, Henan, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

Hunan Brain Hospital

Changsha, Hunan, China

Changsha Central Hospital

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT06766916


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