Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
- Conditions
- PTSD
- Interventions
- Drug: TNX-102 SL
- Registration Number
- NCT02421679
- Lead Sponsor
- Tonix Pharmaceuticals, Inc.
- 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). Patients will not be made aware of the therapy they received during the double-blind study.
- Detailed Description
The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study) and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator.
Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the lead-in study. No patients, investigators, or study staff will know the assigned study treatment from the lead-in study, P201, at the time of entry into the extension study. Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used as one of the baseline values for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance
- Signed informed consent
- Met all prior inclusion and exclusion requirements for lead-in study
- 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
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TNX-102 SL TNX-102 SL TNX-102 SL taken daily at bedtime for 12 weeks
- Primary Outcome Measures
Name Time Method Safety (Adverse events, change in lab test results and vital signs) Week 12 To evaluate the safety of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as new treatment emergent AEs since lead-in study, change in clinical laboratory test results and vital signs
- Secondary Outcome Measures
Name Time Method Response rates a in Total CAPS-5 score Weeks 2, 6 and 12 ≥30% decrease in Total CAPS-5 score at weeks from baseline in lead-in study and since baseline in this study
Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5) Weeks 2, 6 and 12 Changes in total CAPS-5 score from baseline in lead-in study and since baseline in this study
CAPS-5 cluster score items Weeks 2, 6 and 12 Changes from baseline in lead-in study and since baseline in this study in item scores, including
* intrusion symptoms (Criterion B)
* CAPS-5 item 2. (B-2) (unpleasant dreams related to the trauma)
* persistent avoidance (Criterion C),
* negative cognitions and mood (Criterion D)
* arousal and reactivity (Criterion E)Montgomery-Asberg Depression Rating Scale Week 12 Changes from baseline in lead-in study and since baseline in this study in MADRS
PROMIS (Patient -Reported Outcome Measurement Information System) Week 12 Changes from baseline in lead-in study and since baseline in this study in PROMIS scores
MTRSS (Morning Treatment-Related Sedation Scale) Week 12 Changes from baseline in lead-in study and since baseline in this study in MTRSS scores
PGIC (Patient Global Impression of Change Scale) Week 12 Changes from baseline in lead-in study and since baseline in this study in PGIC
Trial Locations
- Locations (22)
CITRIALS
🇺🇸Riverside, California, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Cns, Inc.
🇺🇸Torrance, California, United States
Atlanta Center For Medical Research
🇺🇸Atlanta, Georgia, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
CESAMH
🇺🇸San Diego, California, United States
University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
Tuscaloosa VA Medical Center
🇺🇸Tuscaloosa, Alabama, United States
Synergy Clinical Research
🇺🇸National City, California, United States
Excell Research, Inc
🇺🇸Oceanside, California, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Orange, California, United States
Sun Valley Reserach Center
🇺🇸Imperial, California, United States
Sarkis Clinical Trials
🇺🇸Lake City, Florida, United States
Premier Psychiatric Research Instititute, Inc.
🇺🇸Lincoln, Nebraska, United States
Novex Clinical Research
🇺🇸New Bedford, Massachusetts, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Compass Research North, LLC
🇺🇸Leesburg, Florida, United States
Altea Research
🇺🇸Las Vegas, Nevada, United States
Noesis Pharma
🇺🇸Phoenix, Arizona, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States