A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
- Conditions
- PTSD
- Interventions
- Drug: TNX-102 SL 5.6 mg
- Registration Number
- NCT03508700
- Lead Sponsor
- Tonix Pharmaceuticals, Inc.
- 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).
- Detailed Description
This is an open-label, extension trial designed to evaluate safety over 40 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD.
The study will consist of 5 in-clinic study visits, including Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit of the 12-week open-label extension study TNX-CY-P303), followed by in-clinic visits after 7, 16, 28 and 40 weeks of open-label treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- 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.
- The patient met all prior inclusion and exclusion requirements for the double-blind lead-in HONOR study, or the site received medical monitor approval for the patient to remain in the lead-in study after the retrospective discovery of an entry violation that did not pose any threat to the patient's safety or well-being.
- 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.
- There are no exclusion criteria for this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TNX-102 SL 5.6 mg TNX-102 SL 5.6 mg 2 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
- Primary Outcome Measures
Name Time Method Incidence of Newly Emergent Adverse Events 40 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Little Rock
🇺🇸Little Rock, Arkansas, United States
Norwich
🇺🇸Norwich, Connecticut, United States
Tampa
🇺🇸Tampa, Florida, United States
New Bedford
🇺🇸New Bedford, Massachusetts, United States
Las Vegas
🇺🇸Las Vegas, Nevada, United States
Oceanside
🇺🇸Oceanside, California, United States
Beverly Hills
🇺🇸Beverly Hills, California, United States
Temecula
🇺🇸Temecula, California, United States
Atlanta
🇺🇸Atlanta, Georgia, United States
Cedarhurst
🇺🇸Cedarhurst, New York, United States
Canton
🇺🇸Canton, Ohio, United States
Cincinnati
🇺🇸Cincinnati, Ohio, United States
Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
New York
🇺🇸New York, New York, United States
Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Orange
🇺🇸Orange, California, United States