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A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD — RECOVERY  

PTSD Clinical Trial

Official title:
A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)

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 TNX-102 SL 5.6 mg (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 NCT03841773
Study type Interventional
Source Tonix Pharmaceuticals, Inc.
Contact
Status Terminated
Phase Phase 3
Start date March 7, 2019
Completion date April 24, 2020
View Details
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