MedTrace Logo

Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions

NCT02421679 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2025-02-06

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

TNX-102 SL

1x 2.8mg TNX-102 SL Sublingual tablet

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Denise Bedoya · Premier Research Group plc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-14
Primary Completion
2016-05-26
Completion
2016-05-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421679 on ClinicalTrials.gov