drugset / Trial / NCT06315790
Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | — | Subcutaneous |