drugset / Trial / NCT06315790

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

NCT06315790

Phase 3 Unknown 80 enrolled Henrik Schytz
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-11-01
Primary completion
2025-10-01
Completion
2025-10-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic Subcutaneous

Indications