NCT06766916

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-05-07
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2025-01-09
• Last updated: 2025-05-18

Locations

11 sites across 1 country: China