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

NCT06410859 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-05-13

No results posted yet for this study

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.

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)

Sponsors & Collaborators

  • LKGS_277

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06410859 on ClinicalTrials.gov