Study Stopped
Stopped early due to inadequate separation on primary efficacy endpoint in the lead-in HONOR study, TNX-CY-P301
12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
A 12-Week Open-Label Extension Study to Evaluate TNX-102 SL Taken Daily at Bedtime in Patients With PTSD
1 other identifier
interventional
190
1 country
32
Brief Summary
This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.
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 Jun 2017
Shorter than P25 for phase_3
32 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
March 31, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2018
CompletedResults Posted
Study results publicly available
February 6, 2025
CompletedFebruary 6, 2025
February 1, 2025
1.1 years
March 31, 2017
January 12, 2025
February 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed a Double-blinded lead-in Study
Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class.
12 weeks
Secondary Outcomes (1)
Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score
Day 1 of TNX-CY-P301 (Week -12 of TNX-CY-P303), Day 1 of TNX-CY-P303, Week 12 of TNX-CY-P303
Study Arms (1)
TNX-102 SL
EXPERIMENTAL2 x TNX-102 SL, 2.8 mg tablets taken daily at bedtime for 12 weeks
Interventions
2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks
Eligibility Criteria
You may qualify if:
- The patient has completed the final treatment study visit of the lead-in study and remained compliant with the lead-in protocol and study treatment.
- The patient has provided written informed consent to participate in this extension protocol.
- Female patients of childbearing potential continue to agree to practice one of the medically acceptable methods of birth control detailed in the lead-in study.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tonix Pharmaceuticals, Inc.lead
- Premier Researchcollaborator
Study Sites (32)
Phoenix
Phoenix, Arizona, 85032, United States
Rogers
Rogers, Arkansas, 72758, United States
Beverly Hills
Beverly Hills, California, 90210, United States
Glendale
Glendale, California, 91206, United States
Oakland
Oakland, California, 94607, United States
Oceanside
Oceanside, California, 92056, United States
Orange
Orange, California, 92868, United States
Riverside
Riverside, California, 92506, United States
San Diego
San Diego, California, 92123, United States
San Diego
San Diego, California, 92161, United States
Temecula
Temecula, California, 92591, United States
Colorado Springs
Colorado Springs, Colorado, 80910, United States
Jacksonville
Jacksonville, Florida, 32256, United States
Lake City
Lake City, Florida, 32607, United States
Lauderhill
Lauderhill, Florida, 33319, United States
Tampa
Tampa, Florida, 33609, United States
Atlanta
Atlanta, Georgia, 30341, United States
New Bedford
New Bedford, Massachusetts, 02740, United States
Flowood
Flowood, Mississippi, 39232, United States
Las Vegas
Las Vegas, Nevada, 89102, United States
Berlin
Berlin, New Jersey, 08009, United States
Cedarhurst
Cedarhurst, New York, 11516, United States
New York
New York, New York, 10128, United States
Canton
Canton, Ohio, 44718, United States
Cincinnati
Cincinnati, Ohio, 45219, United States
Dayton
Dayton, Ohio, 45417, United States
Oklahoma City
Oklahoma City, Oklahoma, 73103, United States
Charleston
Charleston, South Carolina, 29407, United States
Austin
Austin, Texas, 78754, United States
Dallas
Dallas, Texas, 75231, United States
Houston
Houston, Texas, 77098, United States
San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gregory Sullivan, MD
- 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 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2017
First Posted
April 12, 2017
Study Start
June 20, 2017
Primary Completion
July 27, 2018
Study Completion
July 27, 2018
Last Updated
February 6, 2025
Results First Posted
February 6, 2025
Record last verified: 2025-02