Suspended

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

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What is being tested

TNX-102 SL

Drug
Who is being recruted

Trauma and Stressor Related Disorders+1

+ Mental Disorders

+ Stress Disorders, Post-Traumatic

From 18 to 75 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2017
See protocol details

Summary

Principal SponsorTonix Pharmaceuticals, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 20, 2017

Actual date on which the first participant was enrolled.

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.

Official TitleA 12-Week Open-Label Extension Study to Evaluate TNX-102 SL Taken Daily at Bedtime in Patients With PTSD
NCT03110575
Principal SponsorTonix Pharmaceuticals, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

190 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Trauma and Stressor Related DisordersMental DisordersStress Disorders, Post-TraumaticStress Disorders, Traumatic

Criteria

3 inclusion criteria required to participate
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.
1 exclusion criteria prevent from participating
None.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
2 x TNX-102 SL, 2.8 mg tablets taken daily at bedtime for 12 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 32 locations

Suspended

Phoenix

Phoenix, United StatesOpen Phoenix in Google Maps
Suspended

Rogers

Rogers, United States
Suspended

Beverly Hills

Beverly Hills, United States
Suspended

Glendale

Glendale, United States
Suspended32 Study Centers