Clinical trialNCT03841773TerminatedPhase 3Interventional

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

SponsorTonix Pharmaceuticals, Inc.Enrollment192PTSD

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Gregory M Sullivan, MD
Tonix Pharmaceuticals
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

30 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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
Ashild Peters
Portland, Oregon, United States
Ashild Peters
Salem, Oregon, United States
Ashild Peters
Memphis, Tennessee, United States
Ashild Peters
Austin, Texas, United States
Ashild Peters
Dallas, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Placebo SL TabletsTNX-102 SL

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 7 Mar 2019
Primary completion: 24 Apr 2020
Completion: 24 Apr 2020
Last update posted: 6 Feb 2025
Registered enrollment: 192
Registry id: NCT03841773

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.