NCT06410859

Botulinum Toxin Type A for Injection (HengLi®) in the Treatment of Trigeminal Neuralgia

A Randomized, Double-blind, Parallel, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of Botulinum Toxin Type A for Injection (HengLi®) in the Treatment of Trigeminal Neuralgia

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: LKGS_277 · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of trigeminal neuralgia (TN), so as to determine the optimal dosing regimen of the best administration scheme of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.

Detailed description

This study plans to enroll 240 subjects, and the efficacy measures \[VAS score, DSIS score, daily pain duration (if applicable), and number of daily pain episodes\] will be collected from subjects using the electronic Patient-Reported Outcomes (ePRO) throughout the study. The study period mainly consists of a screening period (14 days before the first dose), a double-blind treatment period (from the first dose to Week 12), and an extension period (from Week 13 to Week 52), including a maximum of 4 treatment cycles (each cycle lasts 12 week)

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A for Injection,also known as "HengLi®"	This study plans to enroll 240 subjects, and the efficacy measures \[VAS score, DSIS score, daily pain duration (if applicable), and number of daily pain episodes\] will be collected from subjects using the electronic Patient-Reported Outcomes (ePRO) throughout the study. The study period mainly consists of a screening period (14 days before the first dose), a double-blind treatment period (from the first dose to Week 12), and an extension period (from Week 13 to Week 52), including a maximum of 4 treatment cycles (each cycle lasts 12 week)

Timeline

• Start date: 2024-04-25
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-05-13
• Last updated: 2024-05-13

Locations

1 site across 1 country: China