NCT02277704

Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions

A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken at Bedtime in Subjects With Military-Related PTSD and Related Conditions (Protocol No. TNX-CY-P201) -"AtEase STUDY"

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	TNX-102 SL
DRUG	Placebo

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-10-29
• Last updated: 2024-06-20
• Results posted: 2024-06-20

Locations

23 sites across 1 country: United States