Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tonix Pharmaceuticals, Inc.
With
Premier Research
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female between 18 and 75 years of age, who have served in any branch of the military.
Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5.
Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.
Willing to refrain from use of all other formulations of cyclobenzaprine.
Willing and able to refrain from antidepressants and other excluded medications.
Capable of reading and understanding English and able to provide written informed consent.
If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
Willing and able to comply with all protocol-specified requirements.
You may not be if
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 (e.g., 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 patients who are pregnant or lactating.
History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
Seizure disorder.
Patients with a body mass index (BMI) \> 45.
Has received any other investigational drug within 30 days before Screening.
Previous participation in any other study with TNX-102 SL.
Family member of investigative staff.
Clareo Health | Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
