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Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions

NCT02277704 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2024-06-20

Study results available
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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.

Conditions

Interventions

DRUG

TNX-102 SL

DRUG

Placebo

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Denise Bedoya · Premier Research Group plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02277704 on ClinicalTrials.gov