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

Phase 3

Terminated

• Conditions: PTSD
• Interventions: Drug: TNX-102 SL; Drug: Placebo SL Tablets

• Registration Number: NCT03841773
• Lead Sponsor: Tonix Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Study Start: 2019-03-07
• Primary Completion: 2020-04-24
• Study Completion: 2020-04-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 192

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

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Exclusion Criteria

• Use of antidepressant medication within 2 months of Baseline

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNX-102 SL Tablet 2.8 mg	TNX-102 SL	2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet	Placebo SL Tablets	2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.

Primary Outcome Measures

Name	Time	Method
The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit.	Week 0, Week 4, Week 8 and Week 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline in CGI-S score.	Week 0, Week 4, Week 8 and Week 12

Trial Locations

Locations (1)

Ashild Peters; 🇺🇸 Dallas, Texas, United States