Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions

Completed · Phase 2 · Has a placebo group

Conditions studied: PTSD

In brief

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.

Key facts

Study ID

NCT02277704

Run by

Tonix Pharmaceuticals, Inc.

People needed

245

Starts

2014-10-01

Expected to finish

2016-05-01

Last updated by the study team

2024-06-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between 18 and 65 years of age
• Diagnosed with current PTSD as defined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5),
• For patients with a qualifying Index trauma(s) resulting in PTSD that occurred during military service, military contractor, Department of Homeland Security or law enforcement
• Willing and able to withdraw and refrain from specific therapies (ask PI)
• Use medically acceptable form of contraception (female only)
• Signed informed consent

You may not qualify if…

• Significant traumatic brain injury
• Severe depression
• Bipolar and psychotic disorders
• Increase risk of suicide
• Significant clinical (cardiac, systemic infection, drug/alcohol abuse) or laboratory abnormalities (including positivity for Hep B, Hep C, HIV)
• Unable to wash-out specific medications (ask PI)
• History of violent behavior within past 2 years, unrelated to work duties
• History of drug or alcohol abuse within past 6 months
• Positive illegal substance test
• Known hypersensitivity to cyclobenzaprine
• Others: seizure disorders, uncontrolled sleep apnea, BMI>40
• Participation in an investigational study in past 30 days
• In the process of litigating for compensation for a psychiatric disorder
• Females that are pregnant or breastfeeding

Where it is running

• Tuscaloosa VA Medical Center — Tuscaloosa, Alabama, United States
• Noesis Pharma — Phoenix, Arizona, United States
• Sun Valley Research Center — Imperial, California, United States
• National City — National City, California, United States
• Excell Research, Inc — Oceanside, California, United States
• Neuropsychiatric Research Center of Orange County — Orange, California, United States
• CITRIALS — Riverside, California, United States
• Veteran Affairs, San Diego Health Care System — San Diego, California, United States
• Cns, Inc. — Torrance, California, United States
• Sarkis Clinical Trials — Lake City, Florida, United States
• Compass Research North, LLC — Leesburg, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Atlanta Center For Medical Research — Atlanta, Georgia, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• Novex Clinical Research — New Bedford, Massachusetts, United States
• Premier Psychiatric Research Institute, Inc. — Lincoln, Nebraska, United States
• Altea Research — Las Vegas, Nevada, United States
• Cedarhurst — Cedarhurst, New York, United States
• Cincinnati — Cincinnati, Ohio, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• IPS Research Company — Oklahoma City, Oklahoma, United States
• Clinical Trials of Texas — San Antonio, Texas, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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