Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD (HONOR)

September 9, 2019 updated by: Tonix Pharmaceuticals, Inc.

A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients With Military-Related PTSD

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Phase 3

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
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Phoenix
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Little Rock
      • Rogers, Arkansas, United States, 72758
        • Rogers
    • California
      • Beverly Hills, California, United States, 90210
        • Beverly Hills
      • Glendale, California, United States, 91206
        • Glendale
      • Oakland, California, United States, 94607
        • Oakland
      • Oceanside, California, United States, 92056
        • Oceanside
      • Orange, California, United States, 92868
        • Orange
      • Riverside, California, United States, 92506
        • Riverside
      • San Diego, California, United States, 92123
        • San Diego
      • San Diego, California, United States, 92161
        • San Diego
      • Temecula, California, United States, 92591
        • Temecula
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Colorado Springs
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Cromwell
      • Norwich, Connecticut, United States, 06360
        • Norwich
    • District of Columbia
      • Washington, District of Columbia, United States, 20018
        • Washington, D.C.
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Jacksonville
      • Lake City, Florida, United States, 32607
        • Lake City
      • Lauderhill, Florida, United States, 33319
        • Lauderhill
      • Maitland, Florida, United States, 32751
        • Maitland
      • Tampa, Florida, United States, 33609
        • Tampa
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Chicago
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • New Bedford
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Flowood
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • St. Louis
    • Montana
      • Missoula, Montana, United States, 59812
        • Missoula
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Las Vegas
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Berlin
    • 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
      • Dayton, Ohio, United States, 45417
        • Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Oklahoma City
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
        • Downingtown
      • Media, Pennsylvania, United States, 19063
        • Media
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Charleston
    • Texas
      • Austin, Texas, United States, 78754
        • Austin
      • Dallas, Texas, United States, 75231
        • Dallas
      • Houston, Texas, United States, 77098
        • Houston
    • Virginia
      • Salem, Virginia, United States, 24153
        • Salem
    • Washington
      • Everett, Washington, United States, 98201
        • Everett

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female between 18 and 75 years of age, who have served in any branch of the military.
  • Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5.
  • Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.
  • Willing to refrain from use of all other formulations of cyclobenzaprine.
  • Willing and able to refrain from antidepressants and other excluded medications.
  • Capable of reading and understanding English and able to provide written informed consent.
  • If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
  • Willing and able to comply with all protocol-specified requirements.

Exclusion Criteria:

  • Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.
  • Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.
  • Severe depressive symptoms at screening or baseline.
  • Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
  • Use of antidepressant medication within 2 months of baseline.
  • Female patients who are pregnant or lactating.
  • History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
  • Seizure disorder.
  • Patients with a body mass index (BMI) > 45.
  • Has received any other investigational drug within 30 days before Screening.
  • Previous participation in any other study with TNX-102 SL.
  • Family member of investigative staff.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TNX-102 SL Tablet, 2.8 mg
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
Drug: TNX-102 SL
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
Other Names:
  • Low dose cyclobenzaprine sublingual tablets
PLACEBO_COMPARATOR: Placebo SL Tablet
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Drug: Placebo SL Tablet
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
Other Names:
  • Placebo sublingual tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in the total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.
Time Frame: Day 0, Week 4, Week 8 and Week 12
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study.
Day 0, Week 4, Week 8 and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression - Improvement from Initiation of Treatment (CGI-I) score after 12 weeks of treatment.
Time Frame: 12 weeks
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the CGI-I score after 12 weeks of treatment.
12 weeks
Change from baseline in the disruption of social life/leisure activities assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.
Time Frame: Day 0, Week 4, Week 8 and Week 12.
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of social life/leisure activities assessed with the SDS after 12 weeks of treatment.
Day 0, Week 4, Week 8 and Week 12.
Change from baseline in the disruption of work/school activities assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.
Time Frame: Day 0, Week 4, Week 8 and Week 12.
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of work/school activities assessed with the SDS after 12 weeks of treatment.
Day 0, Week 4, Week 8 and Week 12.
Change from baseline in patients' quality of sleep using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance scale after 12 weeks of treatment.
Time Frame: Day 0, Week 4, Week 8 and Week 12.
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in quality of sleep using the PROMIS Sleep Disturbance scale after 12 weeks of treatment.
Day 0, Week 4, Week 8 and Week 12.

Collaborators and Investigators

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

Sponsor

Tonix Pharmaceuticals, Inc.

Collaborators

Premier Research Group plc

Investigators

  • Study Director: Greg Sullivan, MD, Tonix Pharmaceuticals

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)

March 27, 2017

Primary Completion (ACTUAL)

July 27, 2018

Study Completion (ACTUAL)

July 27, 2018

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (ACTUAL)

February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNX-CY-P301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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