drugset / Trial / NCT05372887

Safety and Efficacy Study of TNX-102 SL in Participants With PTSD

NCT05372887

Phase 2 Withdrawn Tonix Pharmaceuticals, Inc.
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

EvaluationDrugModalityDoseRoute
Subject cyclobenzaprine Small molecule 5.6 mg Other