PTSD
Conditions
Keywords
PTSD
Brief summary
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.
Interventions
DRUGTNX-102 SL
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
DRUGPlacebo SL Tablets
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Sponsors
Tonix Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening) * Index trauma must have occurred within 9 years of Screening Visit * Must have occurred when the patient was ≥18 years of age
Exclusion criteria
* Use of antidepressant medication within 2 months of Baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Total CAPS-5 Score | Day 1, Week 12 | The primary efficacy endpoint is the mean change from baseline (Day 1) in the total CAPS-5 score after 12 weeks of treatment. The CAPS-5 is an updated and validated version of a semi-structured interview that has been designed to assess the essential features of PTSD as defined by the DSM-5. The total score ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Severity (CGI-S) | Day 1, Week 12 | Change from baseline (Day 1) in CGI-S score at Week 12. CGI-S range from 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients). |
| Sheehan Disability Scale (SDS) | Day 1, Week 12 | Change from baseline in Sheehan Disability Scale (SDS) total score after 12 weeks of treatment comparing the 5.6 mg treatment arm to placebo. The SDS is a self-report questionnaire that was designed to assess the participant's view of the degree to which symptoms have disrupted work/school, social life/leisure activities, and family life/home responsibilities during the previous two weeks. Score ranges from 0 to 30. A score of 0 means the patient is unimpaired, and a score of 30 means the patient is highly impaired. |
| Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance | Day 1, Week 12 | Change from baseline (Day 1) to Week 12 in the PROMIS Sleep Disturbance scale. The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo SL Tablet 2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks | 93 |
| TNX-102 SL Tablet, 5.6 mg 2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks | 99 |
| Total | 192 |
Baseline characteristics
| Characteristic | Total | Placebo SL Tablet | TNX-102 SL Tablet, 5.6 mg |
|---|---|---|---|
| Age, Continuous | 38.5 years STANDARD_DEVIATION 11.16 | 37.2 years STANDARD_DEVIATION 10.67 | 39.8 years STANDARD_DEVIATION 11.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 16 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 157 Participants | 77 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 11 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 144 Participants | 71 Participants | 73 Participants |
| Region of Enrollment United States | 192 participants | 93 participants | 99 participants |
| Sex: Female, Male Female | 152 Participants | 74 Participants | 78 Participants |
| Sex: Female, Male Male | 40 Participants | 19 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 0 / 99 |
| other Total, other adverse events | 17 / 91 | 46 / 96 |
| serious Total, serious adverse events | 2 / 91 | 0 / 96 |
Outcome results
Primary
Mean Change From Baseline in the Total CAPS-5 Score
The primary efficacy endpoint is the mean change from baseline (Day 1) in the total CAPS-5 score after 12 weeks of treatment. The CAPS-5 is an updated and validated version of a semi-structured interview that has been designed to assess the essential features of PTSD as defined by the DSM-5. The total score ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms.
Time frame: Day 1, Week 12
Population: Results are reported for the mITT population, which includes all randomized participants who have at least a baseline and one post-baseline CAPS-5 assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo SL Tablet | Mean Change From Baseline in the Total CAPS-5 Score | -18.5 units on a scale | Standard Error 1.9 |
| TNX-102 SL Tablet, 5.6 mg | Mean Change From Baseline in the Total CAPS-5 Score | -20.7 units on a scale | Standard Error 1.97 |
Secondary
Clinical Global Impression of Severity (CGI-S)
Change from baseline (Day 1) in CGI-S score at Week 12. CGI-S range from 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients).
Time frame: Day 1, Week 12
Population: Results are reported for the mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo SL Tablet | Clinical Global Impression of Severity (CGI-S) | -1.5 units on a scale | Standard Error 0.17 |
| TNX-102 SL Tablet, 5.6 mg | Clinical Global Impression of Severity (CGI-S) | -2.0 units on a scale | Standard Error 0.18 |
Secondary
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance
Change from baseline (Day 1) to Week 12 in the PROMIS Sleep Disturbance scale. The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.
Time frame: Day 1, Week 12
Population: Results are reported for the mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo SL Tablet | Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance | -9.4 T-score | Standard Error 1.51 |
| TNX-102 SL Tablet, 5.6 mg | Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance | -13.0 T-score | Standard Error 1.57 |
Secondary
Sheehan Disability Scale (SDS)
Change from baseline in Sheehan Disability Scale (SDS) total score after 12 weeks of treatment comparing the 5.6 mg treatment arm to placebo. The SDS is a self-report questionnaire that was designed to assess the participant's view of the degree to which symptoms have disrupted work/school, social life/leisure activities, and family life/home responsibilities during the previous two weeks. Score ranges from 0 to 30. A score of 0 means the patient is unimpaired, and a score of 30 means the patient is highly impaired.
Time frame: Day 1, Week 12
Population: Results are reported for the mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo SL Tablet | Sheehan Disability Scale (SDS) | -7.6 units on a scale | Standard Error 0.97 |
| TNX-102 SL Tablet, 5.6 mg | Sheehan Disability Scale (SDS) | -9.4 units on a scale | Standard Error 1.01 |