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

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: Terminated
• Conditions: PTSD
• Intervention / Treatment: Drug: TNX-102 SL; Drug: Placebo SL Tablets

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

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 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

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in the Total CAPS-5 Score	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

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression of Severity (CGI-S)	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)	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	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

• Sponsor: Tonix Pharmaceuticals, Inc.
• Investigators: Study Director: Gregory M Sullivan, MD, Tonix Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2019
• Primary Completion (Actual): April 24, 2020
• Study Completion (Actual): April 24, 2020

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: PTSD
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; 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-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