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

PTSD Clinical Trial

— RECOVERY  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03841773
• Other study ID #: TNX-CY-P302
• Status: Terminated
• Phase: Phase 3
• Start date: March 7, 2019
• Est. completion date: April 24, 2020

Study information

• Verified date: February 2021
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 192
• Est. completion date: April 24, 2020
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Drug:
• TNX-102 SL
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
• Placebo SL Tablets
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks

Locations

Country	Name	City	State
United States	Ashild Peters	Alpharetta	Georgia
United States	Ashild Peters	Austin	Texas
United States	Ashild Peters	Beverly Hills	California
United States	Ashild Peters	Boston	Massachusetts
United States	Ashild Peters	Colorado Springs	Colorado
United States	Ashild Peters	Dallas	Texas
United States	Ashild Peters	Flowood	Mississippi
United States	Ashild Peters	Jacksonville	Florida
United States	Ashild Peters	Las Vegas	Nevada
United States	Ashild Peters	Lincolnwood	Illinois
United States	Ashild Peters	Little Rock	Arkansas
United States	Ashild Peters	Memphis	Tennessee
United States	Ashild Peters	New Bedford	Massachusetts
United States	Ashild Peters	North Miami	Florida
United States	Ashild Peters	Norwich	Connecticut
United States	Ashild Peters	Oceanside	California
United States	Ashild Peters	Oklahoma City	Oklahoma
United States	Ashild Peters	Orange	California
United States	Ashild Peters	Orlando	Florida
United States	Ashild Peters	Panorama City	California
United States	Ashild Peters	Phoenix	Arizona
United States	Ashild Peters	Portland	Oregon
United States	Ashild Peters	Riverside	California
United States	Ashild Peters	Rogers	Arkansas
United States	Ashild Peters	Saint Louis	Missouri
United States	Ashild Peters	Salem	Oregon
United States	Ashild Peters	San Diego	California
United States	Ashild Peters	Tampa	Florida
United States	Ashild Peters	Temecula	California
United States	Ashild Peters	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in CGI-S score.		Week 0, Week 4, Week 8 and Week 12