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

Status:	Terminated
Conditions:	Psychiatric
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	18 - 75
Updated:	10/5/2018
Start Date:	June 20, 2017
End Date:	July 27, 2018

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

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.

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.

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:

We found this trial at

sites

Investigational Site - Charleston

Charleston, South Carolina

from

Charleston, SC