NCT03841773

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	TNX-102 SL	Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
DRUG	Placebo SL Tablets	Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks

Timeline

• Start date: 2019-03-07
• Primary completion: 2020-04-24
• Completion: 2020-04-24
• First posted: 2019-02-15
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study