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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: PTSD

In brief

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.

Key facts

Study ID

NCT03841773

Run by

Tonix Pharmaceuticals, Inc.

People needed

192

Starts

2019-03-07

Expected to finish

2020-04-24

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Use of antidepressant medication within 2 months of Baseline

Where it is running

• Ashild Peters — Phoenix, Arizona, United States
• Ashild Peters — Little Rock, Arkansas, United States
• Ashild Peters — Rogers, Arkansas, United States
• Ashild Peters — Beverly Hills, California, United States
• Ashild Peters — Oceanside, California, United States
• Ashild Peters — Orange, California, United States
• Ashild Peters — Panorama City, California, United States
• Ashild Peters — Riverside, California, United States
• Ashild Peters — San Diego, California, United States
• Ashild Peters — Temecula, California, United States
• Ashild Peters — Colorado Springs, Colorado, United States
• Ashild Peters — Norwich, Connecticut, United States
• Ashild Peters — Washington D.C., District of Columbia, United States
• Ashild Peters — Jacksonville, Florida, United States
• Ashild Peters — North Miami, Florida, United States
• Ashild Peters — Orlando, Florida, United States
• Ashild Peters — Tampa, Florida, United States
• Ashild Peters — Alpharetta, Georgia, United States
• Ashild Peters — Lincolnwood, Illinois, United States
• Ashild Peters — Boston, Massachusetts, United States
• Ashild Peters — New Bedford, Massachusetts, United States
• Ashild Peters — Flowood, Mississippi, United States
• Ashild Peters — St Louis, Missouri, United States
• Ashild Peters — Las Vegas, Nevada, United States
• Ashild Peters — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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