Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
P202
A 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions
1 other identifier
interventional
159
1 country
22
Brief Summary
This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study) \[NCT02277704\]. Patients will not be made aware of the therapy they received during the double-blind study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2015
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2015
CompletedStudy Start
First participant enrolled
April 14, 2015
CompletedFirst Posted
Study publicly available on registry
April 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2016
CompletedResults Posted
Study results publicly available
February 6, 2025
CompletedFebruary 6, 2025
February 1, 2025
1.1 years
April 9, 2015
April 30, 2024
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Newly Treatment Emergent Adverse Events
Number of patients with new treatment emergent AEs since completing lead-in study
Week 12
Secondary Outcomes (5)
Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)
P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Response Rates a in Total CAPS-5 Score
P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12
CAPS-5 Cluster Score Items
P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Montgomery-Asberg Depression Rating Scale
P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
PROMIS (Patient -Reported Outcome Measurement Information System)
P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Study Arms (1)
TNX-102 SL
EXPERIMENTALTNX-102 SL taken daily at bedtime for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance
- Signed informed consent
- No new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study
- Willing to refrain from use of specific medication (ask PI)
- Female patients of childbearing potential continue to practice medically acceptable methods of birth control
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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
Synergy Clinical Research
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
CESAMH
San Diego, California, 92103, 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
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45219, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2015
First Posted
April 21, 2015
Study Start
April 14, 2015
Primary Completion
May 26, 2016
Study Completion
May 26, 2016
Last Updated
February 6, 2025
Results First Posted
February 6, 2025
Record last verified: 2025-02