PTSD
Conditions
Brief summary
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (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 each day at bedtime starting on Day 1 for 12 weeks
DRUGPlacebo
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime 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 or female between 18 and 75 years of age, at the time of signing ICF, inclusive. * Diagnosed with current (past month) PTSD as determined by the MINI 7.0.2 Module H (PTSD). * Index trauma(s) resulting in PTSD must meet DSM-5 Criterion A for PTSD as described in the CAPS 5, must have occurred within 9 years of Screening Visit 1, and must have occurred when the participant was ≥18 years of age. * Willing and able to withdraw and refrain from opioids for the course of the study. * Willing to refrain from use of all other formulations of cyclobenzaprine for the course of the study. * Willing and able to refrain from antidepressants and other excluded medications. * Capable of reading and understanding English and able to provide written informed consent to participate. * Willing to comply with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. * If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study. * Body mass index (BMI) within the range 17.5 - 35 kg/m\^2 (inclusive).
Exclusion criteria
* Current or ongoing exposure to the trauma that resulted in the PTSD (ie, non-work-related trauma such as ongoing domestic abuse). * Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol. * Significant (eg, moderate or severe) comorbid traumatic brain injury (TBI) by history. * Severe depressive symptoms at screening or baseline. * Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion. * Use of antidepressant medication within 2 months of baseline. * Female participants who are pregnant or lactating. * History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients in TNX-102 SL or placebo formulations. * Seizure disorder. * Current moderate or severe sleep apnea not well controlled by positive airway pressure (PAP) or oral (mouthpiece) devices. * Has received any other investigational drug within 90 days before Screening or has taken cyclobenzaprine within 21 days of the Randomization visit. * Previous participation in any other study with TNX-102 SL. * Family member of investigative staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in the total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12. | Day 1, Week 4, Week 12 | To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (CAPS-5) total symptom severity score in a 12-week study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression - Severity change from Baseline to Week 12 | Day 1, Week 4, Week 8, Week 12 | CGI-S to assess global severity change from baseline to Week 12 |
| Change from baseline in the disruption of psychosocial functioning assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment. | Day 1, Week 4, Week 8, Week 12 | SDS to assess psychosocial functioning change from baseline to Week 12 |
Countries
Kenya
Outcome results
None listed