| Primary | Newly Treatment Emergent Adverse Events | Number of patients with new treatment emergent AEs since completing lead-in study | Results are reported for the safety population, which includes all patients who received at least one dose of investigational product under this protocol. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo- TNX-102 SL 2.8 mg | These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG001 | TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG002 | TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. |
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| Secondary | 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. | Only patients with data available at all timepoints were evaluated. | Posted | | Least Squares Mean | Standard Error | units on a scale | | P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo- TNX-102 SL 2.8 mg | These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG001 | TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG002 | TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. |
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| Secondary | 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. | Any patients with missing values are assigned as not achieving 30% improvement. | Posted | | Count of Participants | | Participants | | P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo- TNX-102 SL 2.8 mg | These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG001 | TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG002 | TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. |
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| Secondary | 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
| Only patients with data available at all timepoints were evaluated. | Posted | | Least Squares Mean | Standard Error | units on a scale | | P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo- TNX-102 SL 2.8 mg | These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG001 | TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG002 | TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg |
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| Secondary | 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. | Only patients with data available at all timepoints were evaluated. | Posted | | Least Squares Mean | Standard Error | units on a scale | | P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo- TNX-102 SL 2.8 mg | These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG001 | TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG002 | TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. |
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| Secondary | 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
| Only patients with data available at all timepoints were evaluated. | Posted | | Least Squares Mean | Standard Error | T-score | | P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo- TNX-102 SL 2.8 mg | These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. | | OG001 | TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study. |
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