Study Stopped
Interim Analysis results
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)
1 other identifier
interventional
192
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2019
Shorter than P25 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedStudy Start
First participant enrolled
March 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2020
CompletedResults Posted
Study results publicly available
February 6, 2025
CompletedFebruary 6, 2025
February 1, 2025
1.1 years
February 12, 2019
January 12, 2025
February 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Clinical Global Impression of Severity (CGI-S)
Day 1, Week 12
Sheehan Disability Scale (SDS)
Day 1, Week 12
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance
Day 1, Week 12
Study Arms (2)
TNX-102 SL Tablet 2.8 mg
EXPERIMENTAL2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet
PLACEBO COMPARATOR2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Interventions
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Use of antidepressant medication within 2 months of Baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Ashild Peters
Phoenix, Arizona, 85012, United States
Ashild Peters
Little Rock, Arkansas, 72211, United States
Ashild Peters
Rogers, Arkansas, 72758, United States
Ashild Peters
Beverly Hills, California, 90210, United States
Ashild Peters
Oceanside, California, 92056, United States
Ashild Peters
Orange, California, 92868, United States
Ashild Peters
Panorama City, California, 91402, United States
Ashild Peters
Riverside, California, 92506, United States
Ashild Peters
San Diego, California, 92123, United States
Ashild Peters
Temecula, California, 92591, United States
Ashild Peters
Colorado Springs, Colorado, 80910, United States
Ashild Peters
Norwich, Connecticut, 06360, United States
Ashild Peters
Washington D.C., District of Columbia, 20011, United States
Ashild Peters
Jacksonville, Florida, 32256, United States
Ashild Peters
North Miami, Florida, 33161, United States
Ashild Peters
Orlando, Florida, 32801, United States
Ashild Peters
Tampa, Florida, 33614, United States
Ashild Peters
Alpharetta, Georgia, 30341, United States
Ashild Peters
Lincolnwood, Illinois, 60712, United States
Ashild Peters
Boston, Massachusetts, 02131, United States
Ashild Peters
New Bedford, Massachusetts, 02740, United States
Ashild Peters
Flowood, Mississippi, 39232, United States
Ashild Peters
St Louis, Missouri, 63141, United States
Ashild Peters
Las Vegas, Nevada, 89102, United States
Ashild Peters
Oklahoma City, Oklahoma, 73106, United States
Ashild Peters
Portland, Oregon, 97214, United States
Ashild Peters
Salem, Oregon, 97301, United States
Ashild Peters
Memphis, Tennessee, 38119, United States
Ashild Peters
Austin, Texas, 78737, United States
Ashild Peters
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gregory Sullivan, MD
- Organization
- Tonix Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Gregory M Sullivan, MD
Tonix Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2019
First Posted
February 15, 2019
Study Start
March 7, 2019
Primary Completion
April 24, 2020
Study Completion
April 24, 2020
Last Updated
February 6, 2025
Results First Posted
February 6, 2025
Record last verified: 2025-02