NCT06315790

Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Henrik Schytz · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 1:1.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DRUG	Botulinum toxin A	Subcutaneously injections are given unilaterally in the face at predefined injection sites.
OTHER	Isotonic saline	Subcutaneously injections are given unilaterally in the face at predefined injection sites.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: Denmark