Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT06410859
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-13
First Post:
2024-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botulinum Toxin Type A for Injection (HengLi®) in the Treatment of Trigeminal Neuralgia
Sponsor:
LKGS_277
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: