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

Phase 3

Terminated

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
TNX-102 SL Tablet 2.8 mg	TNX-102 SL	2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet	Placebo SL Tablets	2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in the Total CAPS-5 Score	Day 1, Week 12	The primary efficacy endpoint is the mean change from baseline (Day 1) in the total CAPS-5 score after 12 weeks of treatment. The CAPS-5 is an updated and validated version of a semi-structured interview that has been designed to assess the essential features of PTSD as defined by the DSM-5. The total score ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of Severity (CGI-S)	Day 1, Week 12	Change from baseline (Day 1) in CGI-S score at Week 12. CGI-S range from 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients).
Sheehan Disability Scale (SDS)	Day 1, Week 12	Change from baseline in Sheehan Disability Scale (SDS) total score after 12 weeks of treatment comparing the 5.6 mg treatment arm to placebo. The SDS is a self-report questionnaire that was designed to assess the participant's view of the degree to which symptoms have disrupted work/school, social life/leisure activities, and family life/home responsibilities during the previous two weeks. Score ranges from 0 to 30. A score of 0 means the patient is unimpaired, and a score of 30 means the patient is highly impaired.
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance	Day 1, Week 12	Change from baseline (Day 1) to Week 12 in the PROMIS Sleep Disturbance scale. The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.