Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

• Status: Terminated
• Trial end date: 2018-07-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tonix Pharmaceuticals, Inc.
• Collaborator: Premier Research Group plc
• Treatments: Cyclobenzaprine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.