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

Tonix Pharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

PTSD

Treatments

Drug: TNX-102 SL

Study type

Interventional

Funder types

Industry

Identifiers

NCT03110575

TNX-CY-P303

Details and patient eligibility

About

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.

Full 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.

Enrollment

190 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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