A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD (RECOVERY)

February 5, 2025 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 in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 85012
        • Ashild Peters
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Ashild Peters
      • Rogers, Arkansas, United States, 72758
        • Ashild Peters
    • California
      • Beverly Hills, California, United States, 90210
        • Ashild Peters
      • Oceanside, California, United States, 92056
        • Ashild Peters
      • Orange, California, United States, 92868
        • Ashild Peters
      • Panorama City, California, United States, 91402
        • Ashild Peters
      • Riverside, California, United States, 92506
        • Ashild Peters
      • San Diego, California, United States, 92123
        • Ashild Peters
      • Temecula, California, United States, 92591
        • Ashild Peters
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Ashild Peters
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Ashild Peters
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Ashild Peters
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Ashild Peters
      • North Miami, Florida, United States, 33161
        • Ashild Peters
      • Orlando, Florida, United States, 32801
        • Ashild Peters
      • Tampa, Florida, United States, 33614
        • Ashild Peters
    • Georgia
      • Alpharetta, Georgia, United States, 30341
        • Ashild Peters
    • Illinois
      • Lincolnwood, Illinois, United States, 60712
        • Ashild Peters
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Ashild Peters
      • New Bedford, Massachusetts, United States, 02740
        • Ashild Peters
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Ashild Peters
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Ashild Peters
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Ashild Peters
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • Ashild Peters
    • Oregon
      • Portland, Oregon, United States, 97214
        • Ashild Peters
      • Salem, Oregon, United States, 97301
        • Ashild Peters
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Ashild Peters
    • Texas
      • Austin, Texas, United States, 78737
        • Ashild Peters
      • Dallas, Texas, United States, 75231
        • Ashild Peters

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
  • Index trauma must have occurred within 9 years of Screening Visit
  • Must have occurred when the patient was ≥18 years of age

Exclusion Criteria:

  • Use of antidepressant medication within 2 months of Baseline

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 starting on Day 1 for 12 weeks
Other Names:
  • Low dose cyclobenzaprine sublingual tablets
  • Tonmya(R)
Placebo Comparator: Placebo SL Tablet
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Drug: Placebo SL Tablets
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Other Names:
  • Placebo sublingual tablets
  • TNX-102 SL Placebo Tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in the Total CAPS-5 Score
Time Frame: Day 1, Week 12
The primary efficacy endpoint is the mean change from baseline (Day 1) in the total CAPS-5 score after 12 weeks of treatment. The CAPS-5 is an updated and validated version of a semi-structured interview that has been designed to assess the essential features of PTSD as defined by the DSM-5. The total score ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms.
Day 1, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Global Impression of Severity (CGI-S)
Time Frame: Day 1, Week 12
Change from baseline (Day 1) in CGI-S score at Week 12. CGI-S range from 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients).
Day 1, Week 12
Sheehan Disability Scale (SDS)
Time Frame: Day 1, Week 12
Change from baseline in Sheehan Disability Scale (SDS) total score after 12 weeks of treatment comparing the 5.6 mg treatment arm to placebo. The SDS is a self-report questionnaire that was designed to assess the participant's view of the degree to which symptoms have disrupted work/school, social life/leisure activities, and family life/home responsibilities during the previous two weeks. 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
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance
Time Frame: Day 1, Week 12
Change from baseline (Day 1) to Week 12 in the PROMIS Sleep Disturbance scale. The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.
Day 1, Week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tonix Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gregory M Sullivan, MD, Tonix Pharmaceuticals

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TNX-CY-P302

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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