12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients

Study Overview
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Brief Summary
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This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.

Detailed Description
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The study will consist of 5 study visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit on double-blind treatment), a phone visit after 2 weeks of treatment, and in-clinic visits after 4, 8, and 12 weeks of treatment. The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study. The secondary objective of the study is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.

Official Title
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A 12-Week Open-Label Extension Study to Evaluate TNX-102 SL Taken Daily at Bedtime in Patients With PTSD

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: The patient has completed the final treatment study visit of the lead-in study and remained compliant with the lead-in protocol and study treatment. The patient has provided written informed consent to participate in this extension protocol. Female patients of childbearing potential continue to agree to practice one of the medically acceptable methods of birth control detailed in the lead-in study. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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>2 x TNX-102 SL, 2.8 mg tablets taken daily at bedtime for 12 weeks | Drug: TNX-102 SL<br>* 2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks<br>* Other names: cyclobenzaprine HCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the incidence of adverse events of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study | Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class. Serious AEs and AEs leading to discontinuation of study drug will also be summarized. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the change from both baselines in the Total CAPS-5 score of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study | The CAPS-5 symptom severity 1-week recall version will be administered by qualified and trained clinicians. | Week 0, 12 | 
| Evaluate the proportion of patients with a CGI-I score of very much improved or much improved of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study | The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline. | Week 4, 8, 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bedtime, TNX-102 SL, Sublingual, 3-month, Safety, Efficacy, PTSD