A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
P306
A 40-week Open-Label Extension Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
1 other identifier
interventional
93
1 country
16
Brief Summary
Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).
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 Apr 2018
16 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 12, 2018
CompletedStudy Start
First participant enrolled
April 19, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedResults Posted
Study results publicly available
February 5, 2025
CompletedFebruary 5, 2025
January 1, 2025
1.4 years
April 12, 2018
January 12, 2025
January 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Newly Emergent Adverse Events
Evaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in 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. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.
40 weeks
Study Arms (1)
TNX-102 SL 5.6 mg
EXPERIMENTAL2 tablets of TNX-102 SL 2.8 mg taken simultaneously and sublingually (under the tongue) each day at bedtime starting on Day 0 for 40 weeks
Interventions
Eligibility Criteria
You may qualify if:
- The patient has completed a double-blind lead-in HONOR study and a 12-week open-label extension study P303 and is judged by the investigator as reasonably compliant, with at least 60% compliance with study medication usage (based on drug accountability).
- The patient has provided written informed consent to participate in this extension study.
- During the course of the lead-in HONOR study or 12-week open-label extension P303 study, the patient has had no intervening medical conditions including pregnancy, clinically significant increase in suicidal ideation (plan or intent) or significant worsening of depression, newly arising clinically significant abnormal laboratory tests, or any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the patient's ability to participate in the study or potentially compromise the patient's well-being during the study.
- The patient does not require treatment with a potent (strong) cytochrome P450 subtype 3A4 (CYP3A4) inhibitor, or St. John's wort.
- The patient is willing to refrain from use of all other formulations of cyclobenzaprine for the duration of the study.
- The patient is willing to refrain from use of monoamine oxidase inhibitors for the duration of the study.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Little Rock
Little Rock, Arkansas, 72211, United States
Beverly Hills
Beverly Hills, California, 90210, United States
Oceanside
Oceanside, California, 92056, United States
Orange
Orange, California, 92868, United States
Temecula
Temecula, California, 92591, United States
Colorado Springs
Colorado Springs, Colorado, 80910, United States
Norwich
Norwich, Connecticut, 06360, United States
Tampa
Tampa, Florida, 33609, United States
Atlanta
Atlanta, Georgia, 30341, United States
New Bedford
New Bedford, Massachusetts, 02740, United States
Las Vegas
Las Vegas, Nevada, 89102, 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
Oklahoma City
Oklahoma City, Oklahoma, 73103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gregory Sullivan
- Organization
- Tonix Pharmaceuticals
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
April 12, 2018
First Posted
April 26, 2018
Study Start
April 19, 2018
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
February 5, 2025
Results First Posted
February 5, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share