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12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients

NCT03110575 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-02-06

Study results available
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Summary

This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.

Conditions

Interventions

DRUG

TNX-102 SL

2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • 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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2018-07-27
Completion
2018-07-27
FDA Drug
Yes

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 NCT03110575 on ClinicalTrials.gov