CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 245 enrolled
Drug / intervention
TNX-102 SL +1 moredrug
Likely dose
Not stated in 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/NCT02277704
NCT02277704Phase 2Completed
CompareCT.gov

A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken at Bedtime in Subjects With Military-Related PTSD and Related Conditions (Protocol No. TNX-CY-P201) -"AtEase STUDY"

Tonix Pharmaceuticals, Inc.·interventional·Posted Oct 29, 2014·Updated Jun 20, 2024

In Brief

A Phase 2 clinical trial evaluating TNX-102 SL and Placebo for PTSD. Completed, enrolled 245 participants across 23 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 29, 2014
Enrollment StartOct 1, 2014
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.7 years ago

Interventions

TNX-102 SLdrug

Placebodrug