Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions

Phase 2

Completed

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) \[NCT02277704\]. 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

Inclusion Criteria

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

Exclusion Criteria

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
Newly Treatment Emergent Adverse Events	Week 12	Number of patients with new treatment emergent AEs since completing lead-in study

Secondary Outcome Measures

Name	Time	Method
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	Changes in total CAPS-5 score from baseline in lead-in study and since baseline in this study. CAPS-5 score ranges from 0-80 with lower scores indicating less sever PTSD symptoms.
Response Rates a in Total CAPS-5 Score	P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12	≥30% decrease in Total CAPS-5 score from baseline in lead-in study and since baseline in this study. Lower scores on CAPS-5 indicate less severe PTSD symptoms.
CAPS-5 Cluster Score Items	P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12	Changes from baseline in lead-in study and since baseline in this study in item scores, including * intrusion symptoms (Criterion B) - Score ranges from 0 to 20. * CAPS-5 item 2. (B-2) (unpleasant dreams related to the trauma) - Score ranges from 0 to 4 * persistent avoidance (Criterion C) - Score ranges from 0 to 8 * negative cognitions and mood (Criterion D) - Score ranges from 0 to 28 * arousal and reactivity (Criterion E) - Score ranges from 0 to 24 Lower scores indicate less severe symptoms on all items
Montgomery-Asberg Depression Rating Scale	P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12	Changes from baseline in lead-in study and since baseline in this study in MADRS. Score ranges from 0 to 60. Lower scores indicate less severe depression symptoms.
PROMIS (Patient -Reported Outcome Measurement Information System)	P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12	Changes from baseline in lead-in study and since baseline in this study in PROMIS scores. Raw scores are converted to T-scores with mean of 50 and standard deviation of 10 using published conversion tables based on the US population. * Fatigue T-score ranges from 33.1 to 77.8. Lower scores indicate less fatigue * Sleep Disturbance T-score ranges from 28.9 to 76.5. Lower scores indicate less sleep disturbance * Global Physical Health T-score ranges from 16.2 to 67.7. Lower scores indicate better physical health * Global Mental Health T-score ranges from 21.2 to 67.6. Lower scores indicate better mental health

Trial Locations

Locations (22): Cns, Inc.
🇺🇸
Torrance, California, United States
Sarkis Clinical Trials
🇺🇸
Lake City, Florida, United States
Compass Research North, LLC
🇺🇸
Leesburg, Florida, United States
Tuscaloosa VA Medical Center
🇺🇸
Tuscaloosa, Alabama, United States
Noesis Pharma
🇺🇸
Phoenix, Arizona, United States
Sun Valley Research Center
🇺🇸
Imperial, California, 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
CITRIALS
🇺🇸
Riverside, California, United States
CESAMH
🇺🇸
San Diego, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Orlando, Florida, United States
Atlanta Center For Medical Research
🇺🇸
Atlanta, Georgia, United States
Great Lakes Clinical Trials
🇺🇸
Chicago, Illinois, United States
Novex Clinical Research
🇺🇸
New Bedford, Massachusetts, United States
Premier Psychiatric Research Institute, Inc.
🇺🇸
Lincoln, Nebraska, United States
Altea Research
🇺🇸
Las Vegas, Nevada, United States
Neurobehavioral Research, Inc.
🇺🇸
Cedarhurst, New York, United States
University of Cincinnati College of Medicine
🇺🇸
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
🇺🇸
Cleveland, Ohio, United States
Clinical Trials of Texas
🇺🇸
San Antonio, Texas, United States
Northwest Clinical Research Center
🇺🇸
Bellevue, Washington, United States