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

PTSD Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03110575
Study type Interventional
Source Tonix Pharmaceuticals, Inc.
Contact
Status Terminated
Phase Phase 3
Start date June 20, 2017
Completion date July 27, 2018
View Details
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