Phase 2
Completed N=159
Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
Source: ClinicalTrials.gov NCT02421679 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Newly Treatment Emergent Adverse Events — 37; 20; 14 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Newly Treatment Emergent Adverse Events |
37; 20; 14 | — |
| SECONDARY Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5) |
-25.3; -25.6; -26.9; -4.9; -4.8; -3.7 | — |
| SECONDARY Response Rates a in Total CAPS-5 Score |
43; 47; 30; 20; 24; 13 | — |
| SECONDARY CAPS-5 Cluster Score Items |
-7.7; -7.4; -7.7; -1.9; -1.5; -1.4 | — |
| SECONDARY Montgomery-Asberg Depression Rating Scale |
-8.1; -9.3; -9.9; 0.1; -1.1; -2.1 | — |
| SECONDARY PROMIS (Patient -Reported Outcome Measurement Information System) |
-10.4; -12.2; -14.3; 0.7; 0.4; -3.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02421679). 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.