Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315790
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-08-28
Brief Title:
Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia
Sponsor:
Henrik Schytz
Organization:
Danish Headache Center
Study Overview
Official Title:
Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia a Double-blind Randomized Placebo-controlled Parallel-group Trial and Investigation of Neuro-inflammatory Biomarkers as Predictors of Efficacy
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers The trial lasts 16 weeks with a 4-week baseline phase and a 12-week randomization phase Four visits are planned 1 Introduction and baseline data collection 2 Medical evaluation and treatment assignment 3 Follow-up with biomarker analysis and 4 Trial conclusion interview 80 participants will be included and randomized 11
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None