A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD (P306)

A 40-week Open-Label Extension Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Drug: TNX-102 SL 5.6 mg

Detailed Description

This is an open-label, extension trial designed to evaluate safety over 40 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD.

The study will consist of 5 in-clinic study visits, including Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit of the 12-week open-label extension study TNX-CY-P303), followed by in-clinic visits after 7, 16, 28 and 40 weeks of open-label treatment.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Little Rock
  • California
    • Beverly Hills, California, United States, 90210
      • Beverly Hills
    • Oceanside, California, United States, 92056
      • Oceanside
    • Orange, California, United States, 92868
      • Orange
    • Temecula, California, United States, 92591
      • Temecula
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Colorado Springs
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich
  • Florida
    • Tampa, Florida, United States, 33609
      • Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30341
      • Atlanta
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • New Bedford
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Las Vegas
  • New York
    • Cedarhurst, New York, United States, 11516
      • Cedarhurst
    • New York, New York, United States, 10128
      • New York
  • Ohio
    • Canton, Ohio, United States, 44718
      • Canton
    • Cincinnati, Ohio, United States, 45219
      • Cincinnati
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Oklahoma City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient has completed a double-blind lead-in HONOR study and a 12-week open-label extension study P303 and is judged by the investigator as reasonably compliant, with at least 60% compliance with study medication usage (based on drug accountability).
• The patient has provided written informed consent to participate in this extension study.
• The patient met all prior inclusion and exclusion requirements for the double-blind lead-in HONOR study, or the site received medical monitor approval for the patient to remain in the lead-in study after the retrospective discovery of an entry violation that did not pose any threat to the patient's safety or well-being.
• During the course of the lead-in HONOR study or 12-week open-label extension P303 study, the patient has had no intervening medical conditions including pregnancy, clinically significant increase in suicidal ideation (plan or intent) or significant worsening of depression, newly arising clinically significant abnormal laboratory tests, or any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the patient's ability to participate in the study or potentially compromise the patient's well-being during the study.
• The patient does not require treatment with a potent (strong) cytochrome P450 subtype 3A4 (CYP3A4) inhibitor, or St. John's wort.
• The patient is willing to refrain from use of all other formulations of cyclobenzaprine for the duration of the study.
• The patient is willing to refrain from use of monoamine oxidase inhibitors for the duration of the study.
• 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:

• There are no exclusion criteria for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNX-102 SL 5.6 mg; 2 tablets of TNX-102 SL 2.8 mg taken simultaneously and sublingually (under the tongue) each day at bedtime starting on Day 0 for 40 weeks	Drug: TNX-102 SL 5.6 mg; cyclobenzaprine HCl sublingual tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Newly Emergent Adverse Events	Evaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in a double-blinded lead-in study. Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.	40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the proportion of patients with a CGI-I score of "very much improved" or "much improved" of TNX-102 SL tablets taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blinded lead-in study	The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline.	Weeks 7, 16, 28, and 40

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: PTSD; Safety; Sublingual; TNX-102 SL; Bedtime
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: TNX-CY-P306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No