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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
159
1x 2.8mg TNX-102 SL Sublingual tablet
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States
Newly Treatment Emergent Adverse Events
Number of patients with new treatment emergent AEs since completing lead-in study
Time frame: Week 12
Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)
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.
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Response Rates a in Total CAPS-5 Score
≥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.
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12
CAPS-5 Cluster Score Items
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
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Montgomery-Asberg Depression Rating Scale
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.
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
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PROMIS (Patient -Reported Outcome Measurement Information System)
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
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12