Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
AtEase
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"
1 other identifier
interventional
245
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2014
23 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
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 23, 2014
CompletedFirst Posted
Study publicly available on registry
October 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
June 20, 2024
CompletedJune 20, 2024
May 1, 2024
1.6 years
October 23, 2014
May 24, 2024
May 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 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 Outcomes (3)
Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment
Day 1, Week 12
Clinician Global Impression - Improvement Scale Responder Rate at Week 12
Week 12
Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score
Day 1, Week 12
Study Arms (3)
Placebo
PLACEBO COMPARATOR2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
TNX-102 SL, 2.8 mg
ACTIVE COMPARATOR1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
TNX-102 SL, 5.6 mg
ACTIVE COMPARATOR2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, 35404, United States
Noesis Pharma
Phoenix, Arizona, 85032, United States
Sun Valley Research Center
Imperial, California, 92251, United States
National City
National City, California, 91950, United States
Excell Research, Inc
Oceanside, California, 92506, United States
Neuropsychiatric Research Center of Orange County
Orange, California, 92868, United States
CITRIALS
Riverside, California, 92506, United States
Veteran Affairs, San Diego Health Care System
San Diego, California, 92161, United States
Cns, Inc.
Torrance, California, 90502, United States
Sarkis Clinical Trials
Lake City, Florida, 32025, United States
Compass Research North, LLC
Leesburg, Florida, 34748, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Atlanta Center For Medical Research
Atlanta, Georgia, 30308, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Novex Clinical Research
New Bedford, Massachusetts, 02740, United States
Premier Psychiatric Research Institute, Inc.
Lincoln, Nebraska, 68526, United States
Altea Research
Las Vegas, Nevada, 89102, United States
Cedarhurst
Cedarhurst, New York, 11516, United States
Cincinnati
Cincinnati, Ohio, 45219, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Related Publications (1)
Sullivan GM, Gendreau RM, Gendreau J, Peters P, Peters A, Engels J, Daugherty BL, Vaughn B, Weathers FW, Lederman S. Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response. Psychiatry Res. 2021 Jul;301:113974. doi: 10.1016/j.psychres.2021.113974. Epub 2021 Apr 30.
PMID: 33979763RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gregory M. Sullivan, Chief Medical Officer
- Organization
- Tonix Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Denise Bedoya
Premier Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
October 23, 2014
First Posted
October 29, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 20, 2024
Results First Posted
June 20, 2024
Record last verified: 2024-05