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

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.

• TNX-102 SL (Drug), also known as cyclobenzaprine HCl: 2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks

Primary outcomes

• Incidence of Newly Emergent 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 [12 weeks]: 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.

Secondary outcomes

• Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score [Day 1 of TNX-CY-P301 (Week -12 of TNX-CY-P303), Day 1 of TNX-CY-P303, Week 12 of TNX-CY-P303]: The CAPS-5 symptom severity 1-week recall version will be administered by qualified and trained clinicians. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms.

Sex: All, ages: 18 Years to 75 Years

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.

Participant flow

Outcome results

• Incidence of Newly Emergent 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 (Primary), Count of participants, Participants: Placebo - TNX-102 SL 62; TNX-102 SL - TNX-102 SL 40
• Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score (Secondary), Least squares mean, units on a scale: Placebo - TNX-102 SL -24.5 +/- 2.43; TNX-102 SL - TNX-102 SL -24.2 +/- 2.64

Adverse events

Time frame: 12 Weeks

Other adverse events by term

• Study Protocol (PDF, 2017-03-31)
• Statistical Analysis Plan (PDF, 2024-03-26)

• Denise Bedoya, Study director, Premier Research