Phase 2
Completed N=245
Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
Source: ClinicalTrials.gov NCT02277704 ↗Enrolled (actual)
245
Serious AEs
1.7%
Results posted
Jun 2024
Primary outcomePrimary: The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12). — -17.0; -19.2; -21.5 units on a scale
Summary
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12). |
-17.0; -19.2; -21.5 | — |
| SECONDARY Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment |
-7.9; -11.1; -11.0 | — |
| SECONDARY Clinician Global Impression - Improvement Scale Responder Rate at Week 12 |
41; 48; 31 | — |
| SECONDARY Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score |
-6.4; -7.9; -8.7 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female between 18 and 65 years of age
- Diagnosed with current PTSD as defined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5),
- For patients with a qualifying Index trauma(s) resulting in PTSD that occurred during military service, military contractor, Department of Homeland Security or law enforcement
- Willing and able to withdraw and refrain from specific therapies (ask PI)
- Use medically acceptable form of contraception (female only)
- Signed informed consent
Exclusion Criteria
- Significant traumatic brain injury
- Severe depression
- Bipolar and psychotic disorders
- Increase risk of suicide
- Significant clinical (cardiac, systemic infection, drug/alcohol abuse) or laboratory abnormalities (including positivity for Hep B, Hep C, HIV)
- Unable to wash-out specific medications (ask PI)
- History of violent behavior within past 2 years, unrelated to work duties
- History of drug or alcohol abuse within past 6 months
- Positive illegal substance test
- Known hypersensitivity to cyclobenzaprine
- Others: seizure disorders, uncontrolled sleep apnea, BMI>40
- Participation in an investigational study in past 30 days
- In the process of litigating for compensation for a psychiatric disorder
- Females that are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT02277704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.