drugset / Trial / NCT05372887
Safety and Efficacy Study of TNX-102 SL in Participants With PTSD
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.
Timeline
- Start
- 2022-10-14
- Primary completion
- 2022-11-08
- Completion
- 2022-11-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cyclobenzaprine | Small molecule | 5.6 mg | Other |