NCT03110575

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	TNX-102 SL	2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks

Timeline

• Start date: 2017-06-20
• Primary completion: 2018-07-27
• Completion: 2018-07-27
• First posted: 2017-04-12
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study