Safety and Efficacy Study of TNX-102 SL in Patients With Military-related 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 5.6 mg TNX-102 SL (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

NCT03062540

Run by

Tonix Pharmaceuticals, Inc.

People needed

358

Starts

2017-03-27

Expected to finish

2018-07-27

Last updated by the study team

2024-05-22

Who can join

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

You may qualify if…

• Male or female between 18 and 75 years of age, who have served in any branch of the military.
• Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5.
• Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.
• Willing to refrain from use of all other formulations of cyclobenzaprine.
• Willing and able to refrain from antidepressants and other excluded medications.
• Capable of reading and understanding English and able to provide written informed consent.
• If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
• Willing and able to comply with all protocol-specified requirements.

You may not qualify if…

• Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.
• Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.
• Severe depressive symptoms at screening or baseline.
• Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
• Use of antidepressant medication within 2 months of baseline.
• Female patients who are pregnant or lactating.
• History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
• Seizure disorder.
• Patients with a body mass index (BMI) > 45.
• Has received any other investigational drug within 30 days before Screening.
• Previous participation in any other study with TNX-102 SL.
• Family member of investigative staff.

Where it is running

• Phoenix — Phoenix, Arizona, United States
• Little Rock — Little Rock, Arkansas, United States
• Rogers — Rogers, Arkansas, United States
• Beverly hills — Beverly Hills, California, United States
• Glendale — Glendale, California, United States
• Oakland — Oakland, California, United States
• Oceanside — Oceanside, California, United States
• Orange — Orange, California, United States
• Riverside — Riverside, California, United States
• San Diego — San Diego, California, United States
• San Diego — San Diego, California, United States
• Temecula — Temecula, California, United States
• Colorado Springs — Colorado Springs, Colorado, United States
• Cromwell — Cromwell, Connecticut, United States
• Norwich — Norwich, Connecticut, United States
• Washington, D.C. — Washington D.C., District of Columbia, United States
• Jacksonville — Jacksonville, Florida, United States
• Lake City — Lake City, Florida, United States
• Lauderhill — Lauderhill, Florida, United States
• Maitland — Maitland, Florida, United States
• Tampa — Tampa, Florida, United States
• Atlanta — Atlanta, Georgia, United States
• Chicago — Chicago, Illinois, United States
• New Bedford — New Bedford, Massachusetts, United States
• Flowood — Flowood, Mississippi, United States

Full record on ClinicalTrials.gov

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