At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 159 enrolled
Drug / intervention
TNX-102 SLdrug
Likely dose
TNX-102 SL 2.8mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions
In Brief
A Phase 2 clinical trial evaluating TNX-102 SL for PTSD. Completed, enrolled 159 participants across 22 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedApr 2015
Primary CompletionMay 2016
TodayJul 2026
First PostedApr 21, 2015
Enrollment StartApr 14, 2015
Primary CompletionMay 26, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.2 years ago
Interventions
TNX-102 SLdrug
1x 2.8mg TNX-102 SL Sublingual tablet