Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions (P202)

A 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions

This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study) [NCT02277704]. Patients will not be made aware of the therapy they received during the double-blind study.

Study Overview

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

Detailed Description

The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study) and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator.

Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the lead-in study. No patients, investigators, or study staff will know the assigned study treatment from the lead-in study, P201, at the time of entry into the extension study. Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used as one of the baseline values for this study.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35404
      • Tuscaloosa VA Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Noesis Pharma
  • California
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • National City, California, United States, 91950
      • Synergy Clinical Research
    • Oceanside, California, United States, 92506
      • Excell Research, Inc
    • Orange, California, United States, 92868
      • Neuropsychiatric Research Center of Orange County
    • Riverside, California, United States, 92506
      • CiTrials
    • San Diego, California, United States, 92103
      • CESAMH
    • Torrance, California, United States, 90502
      • Cns, Inc.
  • Florida
    • Lake City, Florida, United States, 32025
      • Sarkis Clinical Trials
    • Leesburg, Florida, United States, 34748
      • Compass Research North, LLC
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • Novex Clinical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Premier Psychiatric Research Institute, Inc.
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research
  • New York
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati College of Medicine
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance
• Signed informed consent
• Met all prior inclusion and exclusion requirements for lead-in study
• No new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study
• Willing to refrain from use of specific medication (ask PI)
• Female patients of childbearing potential continue to practice medically acceptable methods of birth control

Exclusion Criteria:

• None

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; TNX-102 SL taken daily at bedtime for 12 weeks	Drug: TNX-102 SL; 1x 2.8mg TNX-102 SL Sublingual tablet; Other Names: cyclobenzaprine HCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newly Treatment Emergent Adverse Events	Number of patients with new treatment emergent AEs since completing lead-in study	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)	Changes in total CAPS-5 score from baseline in lead-in study and since baseline in this study. CAPS-5 score ranges from 0-80 with lower scores indicating less sever PTSD symptoms.	P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Response Rates a in Total CAPS-5 Score	≥30% decrease in Total CAPS-5 score from baseline in lead-in study and since baseline in this study. Lower scores on CAPS-5 indicate less severe PTSD symptoms.	P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12
CAPS-5 Cluster Score Items	Changes from baseline in lead-in study and since baseline in this study in item scores, including; intrusion symptoms (Criterion B) - Score ranges from 0 to 20.; CAPS-5 item 2. (B-2) (unpleasant dreams related to the trauma) - Score ranges from 0 to 4; persistent avoidance (Criterion C) - Score ranges from 0 to 8; negative cognitions and mood (Criterion D) - Score ranges from 0 to 28; arousal and reactivity (Criterion E) - Score ranges from 0 to 24 Lower scores indicate less severe symptoms on all items	P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Montgomery-Asberg Depression Rating Scale	Changes from baseline in lead-in study and since baseline in this study in MADRS. Score ranges from 0 to 60. Lower scores indicate less severe depression symptoms.	P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
PROMIS (Patient -Reported Outcome Measurement Information System)	Changes from baseline in lead-in study and since baseline in this study in PROMIS scores. Raw scores are converted to T-scores with mean of 50 and standard deviation of 10 using published conversion tables based on the US population.; Fatigue T-score ranges from 33.1 to 77.8. Lower scores indicate less fatigue; Sleep Disturbance T-score ranges from 28.9 to 76.5. Lower scores indicate less sleep disturbance; Global Physical Health T-score ranges from 16.2 to 67.7. Lower scores indicate better physical health; Global Mental Health T-score ranges from 21.2 to 67.6. Lower scores indicate better mental health	P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.
• Investigators: Study Director: Denise Bedoya, Premier Research Group plc

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2015
• Primary Completion (Actual): May 26, 2016
• Study Completion (Actual): May 26, 2016

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (Estimated): April 21, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: PTSD; Military-related PTSD and other related conditions; open-label extension
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Pathologic Processes; Stress Disorders, Traumatic; Disease; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Neuromuscular Agents; Muscle Relaxants, Central; Antidepressive Agents, Tricyclic; Cyclobenzaprine
• Other Study ID Numbers: TNX-CY-P202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No