Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions (AtEase)

May 24, 2024 updated by: Tonix Pharmaceuticals, Inc.

A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken at Bedtime in Subjects With Military-Related PTSD and Related Conditions (Protocol No. TNX-CY-P201) -"AtEase STUDY"

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • National City
      • 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, 92161
        • Veteran Affairs, San Diego Health Care System
      • 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
        • Cedarhurst
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female between 18 and 65 years of age
  • Diagnosed with current PTSD as defined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5),
  • For patients with a qualifying Index trauma(s) resulting in PTSD that occurred during military service, military contractor, Department of Homeland Security or law enforcement
  • Willing and able to withdraw and refrain from specific therapies (ask PI)
  • Use medically acceptable form of contraception (female only)
  • Signed informed consent

Exclusion Criteria:

  • Significant traumatic brain injury
  • Severe depression
  • Bipolar and psychotic disorders
  • Increase risk of suicide
  • Significant clinical (cardiac, systemic infection, drug/alcohol abuse) or laboratory abnormalities (including positivity for Hep B, Hep C, HIV)
  • Unable to wash-out specific medications (ask PI)
  • History of violent behavior within past 2 years, unrelated to work duties
  • History of drug or alcohol abuse within past 6 months
  • Positive illegal substance test
  • Known hypersensitivity to cyclobenzaprine
  • Others: seizure disorders, uncontrolled sleep apnea, BMI>40
  • Participation in an investigational study in past 30 days
  • In the process of litigating for compensation for a psychiatric disorder
  • Females that are pregnant or breastfeeding

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
Drug: Placebo
Active Comparator: TNX-102 SL, 2.8 mg
1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
Drug: Placebo
Drug: TNX-102 SL
Active Comparator: TNX-102 SL, 5.6 mg
2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
Drug: TNX-102 SL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).
Time Frame: Day 1, Week 12
The mean change from baseline (Visit 2) in the Total CAPS-5 score after 12 weeks of treatment evaluated at Visit 9 (Week 12). The primary efficacy comparison will be the change from baseline in total CAPS-5 score for the 2.8 mg treatment arm compared to placebo. CAPS-5 score ranges from 0-80 with lower scores indicating less severe PTSD symptoms.
Day 1, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment
Time Frame: Day 1, Week 12
Change from baseline in patients' quality of sleep using the PROMIS (Patient -Reported Outcome Measurement Information System) Sleep Disturbance scale after 12 weeks of treatment comparing the 2.8 mg treatment arm to placebo. Raw scores are converted to T-scores using published conversion tables. Sleep Disturbance T-score ranges from 28.9 to 76.5. Lower scores indicate less sleep disturbance
Day 1, Week 12
Clinician Global Impression - Improvement Scale Responder Rate at Week 12
Time Frame: Week 12
Responder rates in CGI-I (Clinician Global Impression - Improvement Scale) after 12 weeks of treatment comparing the 2.8 mg treatment arm to placebo. Responder rate is defined as the number of patients scored as either a 1 or 2 on CGI-I at Week 12. The score ranges from 1 to 7 with the following anchors for each score:1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse
Week 12
Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score
Time Frame: Day 1, Week 12
Mean Change from Baseline in SDS Total Score at Week 12. Score ranges from 0 to 30. A score of 0 means the patient is unimpaired, and a score of 30 means the patient is highly impaired.
Day 1, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tonix Pharmaceuticals, Inc.

Investigators

  • Study Director: Denise Bedoya, Premier Research Group plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimated)

October 29, 2014

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNX-CY-P201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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