NCT05372887

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (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 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.

Conditions

• PTSD

Interventions

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

Timeline

• Start date: 2022-10-14
• Primary completion: 2022-11-08
• Completion: 2022-11-08
• First posted: 2022-05-13
• Last updated: 2023-12-11

Locations

3 sites across 1 country: Kenya

Regulatory

• FDA-regulated drug study