PTSD
Conditions
Keywords
PTSD, Military-related PTSD and other related conditions, open-label extension
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.
Interventions
DRUGTNX-102 SL
1x 2.8mg TNX-102 SL Sublingual tablet
Sponsors
Tonix Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Newly Treatment Emergent Adverse Events | Week 12 | Number of patients with new treatment emergent AEs since completing lead-in study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 54 |
| 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. | 60 |
| 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. | 35 |
| Total | 149 |
Baseline characteristics
| Characteristic | Total | Placebo- TNX-102 SL 2.8 mg | TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg |
|---|---|---|---|---|
| Age, Continuous | 34.7 years STANDARD_DEVIATION 8.11 | 33.1 years STANDARD_DEVIATION 7 | 35.8 years STANDARD_DEVIATION 8.22 | 35.4 years STANDARD_DEVIATION 9.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 11 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 125 Participants | 43 Participants | 52 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 9 Participants | 16 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 4 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 102 Participants | 36 Participants | 41 Participants | 25 Participants |
| Region of Enrollment United States | 149 participants | 54 participants | 60 participants | 35 participants |
| Sex: Female, Male Female | 10 Participants | 4 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 139 Participants | 50 Participants | 57 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 60 | 0 / 35 |
| other Total, other adverse events | 29 / 54 | 7 / 60 | 3 / 35 |
| serious Total, serious adverse events | 0 / 54 | 0 / 60 | 0 / 35 |
Outcome results
Primary
Newly Treatment Emergent Adverse Events
Number of patients with new treatment emergent AEs since completing lead-in study
Time frame: Week 12
Population: Results are reported for the safety population, which includes all patients who received at least one dose of investigational product under this protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo- TNX-102 SL 2.8 mg | Newly Treatment Emergent Adverse Events | 37 Participants |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | Newly Treatment Emergent Adverse Events | 20 Participants |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | Newly Treatment Emergent Adverse Events | 14 Participants |
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
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Population: Only patients with data available at all timepoints were evaluated.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo- TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion D | -1.1 units on a scale | Standard Error 0.85 |
| Placebo- TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Item B-2 | -1.3 units on a scale | Standard Error 0.23 |
| Placebo- TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion E | -6.8 units on a scale | Standard Error 0.83 |
| Placebo- TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion E | -1.4 units on a scale | Standard Error 0.62 |
| Placebo- TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion B | -7.7 units on a scale | Standard Error 0.82 |
| Placebo- TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion C | -0.4 units on a scale | Standard Error 0.38 |
| Placebo- TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Item B-2 | -0.3 units on a scale | Standard Error 0.2 |
| Placebo- TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion B | -1.9 units on a scale | Standard Error 0.66 |
| Placebo- TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion C | -3.1 units on a scale | Standard Error 0.45 |
| Placebo- TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion D | -7.6 units on a scale | Standard Error 1.1 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion C | -0.5 units on a scale | Standard Error 0.39 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion D | -1.8 units on a scale | Standard Error 0.85 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Item B-2 | -0.4 units on a scale | Standard Error 0.21 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion B | -7.4 units on a scale | Standard Error 0.82 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion E | -6.4 units on a scale | Standard Error 0.84 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Item B-2 | -1.4 units on a scale | Standard Error 0.24 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion D | -8.4 units on a scale | Standard Error 1.12 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion E | -0.9 units on a scale | Standard Error 0.62 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion C | -3.2 units on a scale | Standard Error 0.45 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion B | -1.5 units on a scale | Standard Error 0.66 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion C | -3.1 units on a scale | Standard Error 0.5 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion B | -7.7 units on a scale | Standard Error 0.91 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion B | -1.4 units on a scale | Standard Error 0.74 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Item B-2 | -1.4 units on a scale | Standard Error 0.26 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Item B-2 | -0.2 units on a scale | Standard Error 0.23 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion D | -9.1 units on a scale | Standard Error 1.22 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion C | -0.5 units on a scale | Standard Error 0.42 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion D | -1.4 units on a scale | Standard Error 0.95 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P201 Day 1 to P202 Week 12 in Criterion E | -7.1 units on a scale | Standard Error 0.91 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | CAPS-5 Cluster Score Items | Change from P202 Day 1 to P202 Week 12 in Criterion E | -0.8 units on a scale | Standard Error 0.69 |
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.
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Population: Only patients with data available at all timepoints were evaluated.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo- TNX-102 SL 2.8 mg | Montgomery-Asberg Depression Rating Scale | Change from P202 Day 1 to P202 Week 12 | 0.1 units on a scale | Standard Error 1.28 |
| Placebo- TNX-102 SL 2.8 mg | Montgomery-Asberg Depression Rating Scale | Change from P201 Day 1 to P202 Week 12 | -8.1 units on a scale | Standard Error 1.53 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | Montgomery-Asberg Depression Rating Scale | Change from P201 Day 1 to P202 Week 12 | -9.3 units on a scale | Standard Error 1.57 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | Montgomery-Asberg Depression Rating Scale | Change from P202 Day 1 to P202 Week 12 | -1.1 units on a scale | Standard Error 1.3 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | Montgomery-Asberg Depression Rating Scale | Change from P201 Day 1 to P202 Week 12 | -9.9 units on a scale | Standard Error 1.66 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | Montgomery-Asberg Depression Rating Scale | Change from P202 Day 1 to P202 Week 12 | -2.1 units on a scale | Standard Error 1.4 |
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
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Population: Only patients with data available at all timepoints were evaluated.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo- TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Sleep Disturbance T-scores | -10.4 T-score | Standard Error 2.5 |
| Placebo- TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Sleep Disturbance T-scores | 0.7 T-score | Standard Error 2.36 |
| Placebo- TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Fatigue T-scores | -5.6 T-score | Standard Error 2.05 |
| Placebo- TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Fatigue T-scores | 0.9 T-score | Standard Error 1.78 |
| Placebo- TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Global Mental Health T-scores | 7.1 T-score | Standard Error 1.76 |
| Placebo- TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Global Mental Health T-scores | 0.5 T-score | Standard Error 1.5 |
| Placebo- TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Global Physical Health T-scores | 3.1 T-score | Standard Error 1.5 |
| Placebo- TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Global Physical Health T-scores | -0.7 T-score | Standard Error 1.18 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Global Physical Health T-scores | -0.2 T-score | Standard Error 1.2 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Global Mental Health T-scores | 7.1 T-score | Standard Error 1.79 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Sleep Disturbance T-scores | 0.4 T-score | Standard Error 2.4 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Global Mental Health T-scores | 0.2 T-score | Standard Error 1.53 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Fatigue T-scores | -6.4 T-score | Standard Error 2.08 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Global Physical Health T-scores | 3.2 T-score | Standard Error 1.53 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Sleep Disturbance T-scores | -12.2 T-score | Standard Error 2.58 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Fatigue T-scores | 1.1 T-score | Standard Error 1.79 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Global Mental Health T-scores | 10.1 T-score | Standard Error 1.95 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Fatigue T-scores | -0.4 T-score | Standard Error 1.93 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Global Physical Health T-scores | 1.7 T-score | Standard Error 1.3 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Fatigue T-scores | -8.0 T-score | Standard Error 2.26 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Sleep Disturbance T-scores | -14.3 T-score | Standard Error 2.75 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P201 Day 1 to P202 Week 12 in PROMIS Global Physical Health T-scores | 5.8 T-score | Standard Error 1.66 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Global Mental Health T-scores | 1.8 T-score | Standard Error 1.67 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | PROMIS (Patient -Reported Outcome Measurement Information System) | Change from P202 Day 1 to P202 Week 12 in PROMIS Sleep Disturbance T-scores | -3.1 T-score | Standard Error 2.6 |
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.
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12
Population: Any patients with missing values are assigned as not achieving 30% improvement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo- TNX-102 SL 2.8 mg | Response Rates a in Total CAPS-5 Score | Patients with ≥30% decrease in Total CAPS-5 score from P201 Day 1 to P202 Week 12 | 43 Participants |
| Placebo- TNX-102 SL 2.8 mg | Response Rates a in Total CAPS-5 Score | Patients with ≥30% decrease in Total CAPS-5 score from P202 Day 1 to P202 Week 12 | 20 Participants |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | Response Rates a in Total CAPS-5 Score | Patients with ≥30% decrease in Total CAPS-5 score from P201 Day 1 to P202 Week 12 | 47 Participants |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | Response Rates a in Total CAPS-5 Score | Patients with ≥30% decrease in Total CAPS-5 score from P202 Day 1 to P202 Week 12 | 24 Participants |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | Response Rates a in Total CAPS-5 Score | Patients with ≥30% decrease in Total CAPS-5 score from P201 Day 1 to P202 Week 12 | 30 Participants |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | Response Rates a in Total CAPS-5 Score | Patients with ≥30% decrease in Total CAPS-5 score from P202 Day 1 to P202 Week 12 | 13 Participants |
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.
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Population: Only patients with data available at all timepoints were evaluated.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo- TNX-102 SL 2.8 mg | Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5) | Change from P201 Baseline to P202 Week 12 | -25.3 units on a scale | Standard Error 2.55 |
| Placebo- TNX-102 SL 2.8 mg | Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5) | Change from P202 Baseline to P202 Week 12 | -4.9 units on a scale | Standard Error 1.8 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5) | Change from P201 Baseline to P202 Week 12 | -25.6 units on a scale | Standard Error 2.59 |
| TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg | Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5) | Change from P202 Baseline to P202 Week 12 | -4.8 units on a scale | Standard Error 1.82 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5) | Change from P201 Baseline to P202 Week 12 | -26.9 units on a scale | Standard Error 2.8 |
| TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg | Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5) | Change from P202 Baseline to P202 Week 12 | -3.7 units on a scale | Standard Error 2.01 |