CI

At a glance

ClinicalIndex Comparison Record
Phase 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.

Search/NCT02421679
NCT02421679Phase 2Completed

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

Tonix Pharmaceuticals, Inc.·interventional·Posted Apr 21, 2015·Updated Feb 6, 2025

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
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