CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 93 enrolled
Drug / intervention
TNX-102 SL 5.6 mgdrug
Likely dose
TNX-102 SL 5.6 mgfrom 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/NCT03508700
NCT03508700Phase 3Completed
CompareCT.gov

A 40-week Open-Label Extension Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

Tonix Pharmaceuticals, Inc.·interventional·Posted Apr 26, 2018·Updated Feb 5, 2025

In Brief

A Phase 3 clinical trial evaluating TNX-102 SL 5.6 mg for PTSD. Completed, enrolled 93 participants across 16 sites.

Detailed Summary

Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).

Study Details

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

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 26, 2018
Enrollment StartApr 19, 2018
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.2 years ago

Interventions

TNX-102 SL 5.6 mgdrug

cyclobenzaprine HCl sublingual tablets