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

• Status: Terminated
• Trial end date: 2020-04-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tonix Pharmaceuticals, Inc.
• Treatments: Cyclobenzaprine

Criteria

Inclusion Criteria:

• Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)

• Index trauma must have occurred within 9 years of Screening Visit

• Must have occurred when the patient was ≥18 years of age

Exclusion Criteria:

• Use of antidepressant medication within 2 months of Baseline