Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions

Study Overview
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Brief Summary
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This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study). Patients will not be made aware of the therapy they received during the double-blind study.

Detailed Description
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The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study) and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator. Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the lead-in study. No patients, investigators, or study staff will know the assigned study treatment from the lead-in study, P201, at the time of entry into the extension study. Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used as one of the baseline values for this study.

Official Title
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A 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions

Conditions
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PTSD

Intervention / Treatment
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* Drug: TNX-102 SL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance Signed informed consent Met all prior inclusion and exclusion requirements for lead-in study No new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study Willing to refrain from use of specific medication (ask PI) Female patients of childbearing potential continue to practice medically acceptable methods of birth control Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNX-102 SL<br>TNX-102 SL taken daily at bedtime for 12 weeks | Drug: TNX-102 SL<br>* TNX-102 Sublingual tablets<br>* Other names: cyclobenzaprine HCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Adverse events, change in lab test results and vital signs) | To evaluate the safety of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as new treatment emergent AEs since lead-in study, change in clinical laboratory test results and vital signs | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5) | Changes in total CAPS-5 score from baseline in lead-in study and since baseline in this study | Weeks 2, 6 and 12 | 
| Response rates a in Total CAPS-5 score | ≥30% decrease in Total CAPS-5 score at weeks from baseline in lead-in study and since baseline in this study | Weeks 2, 6 and 12 | 
| CAPS-5 cluster score items | Changes from baseline in lead-in study and since baseline in this study in item scores, including intrusion symptoms (Criterion B) CAPS-5 item 2. (B-2) (unpleasant dreams related to the trauma) persistent avoidance (Criterion C), negative cognitions and mood (Criterion D) arousal and reactivity (Criterion E) | Weeks 2, 6 and 12 | 
| Montgomery-Asberg Depression Rating Scale | Changes from baseline in lead-in study and since baseline in this study in MADRS | Week 12 | 
| PROMIS (Patient -Reported Outcome Measurement Information System) | Changes from baseline in lead-in study and since baseline in this study in PROMIS scores | Week 12 | 
| MTRSS (Morning Treatment-Related Sedation Scale) | Changes from baseline in lead-in study and since baseline in this study in MTRSS scores | Week 12 | 
| PGIC (Patient Global Impression of Change Scale) | Changes from baseline in lead-in study and since baseline in this study in PGIC | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Military-related PTSD and other related conditions, open-label extension