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

PTSD Clinical Trial

Official title:
A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Daily Bedtime TNX-102 SL in Participants With PTSD

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05372887
Study type Interventional
Source Tonix Pharmaceuticals, Inc.
Contact
Status Withdrawn
Phase Phase 2
Start date October 14, 2022
Completion date November 8, 2022
View Details
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