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NCT Number: NCT02421679

Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in 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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tuscaloosa VA Medical Center, Tuscaloosa, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TNX-102 SL

Drug

1x 2.8mg TNX-102 SL Sublingual tablet

Other names: cyclobenzaprine HCI

Primary outcomes

  1. Newly Treatment Emergent Adverse Events

    Time frame: Week 12

    Number of patients with new treatment emergent AEs since completing lead-in study

Secondary outcomes

  1. Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)

    Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12

    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.

  2. Response Rates a in Total CAPS-5 Score

    Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12

    ≥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.

  3. CAPS-5 Cluster Score Items

    Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12

    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

  4. Montgomery-Asberg Depression Rating Scale

    Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12

    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.

  5. PROMIS (Patient -Reported Outcome Measurement Information System)

    Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12

    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

Sponsors and collaborators

Lead sponsor

Tonix Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: P202

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2015
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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