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news.US-based Tonix Pharmaceuticals has completed enrollment of patients for its phase 2 AtEase clinical trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of post-traumatic stress disorder (PTSD).
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The randomized, double-blind, placebo-controlled, registration-quality Phase 2 clinical trial AtEase is being conducted at about 25 US sites.
The study has been designed to assess the safety of TNX-102 SL to treat patients with military-related PTSD.
Tonix said that the enrollment has exceeded the 240-patient goal.
Participants are treated with TNX-102 SL 2.8 mg, TNX-102 SL 5.6 mg, or inactive control.
The endpoint of the trial is the week 12 mean change from baseline score in the clinician-administered PTSD Scale for DSM-5 in participants who received TNX-102 SL 2.8 mg as compared to those who received inactive control.
Tonix Pharmaceuticals president and CEO Seth Lederman said: "We are studying military-related PTSD in our AtEase trial because there is an urgent need to develop PTSD treatments for the veterans who have served our nation.
"AtEase is potentially a landmark study in PTSD research, and we look forward to reporting top-line data from this trial in the second quarter of 2016."
PTSD, which may occur from witnessing or experiencing traumatic events, is linked to negative behavioral outcomes such as suicide.