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

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

April 25, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Trigeminal Neuralgia
Interventions
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)

Trial Locations (1)

100730

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
lead

LKGS_277

INDUSTRY