Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410859
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-13
First Post:
2024-04-14
Brief Title:
Botulinum Toxin Type A for Injection HengLi in the Treatment of Trigeminal Neuralgia
Sponsor:
LKGS_277
Organization:
Lanzhou Institute of Biological Products Co Ltd
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:
None
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?:
None