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Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

NCT03062540 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2024-05-22

Study results available
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Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

Conditions

Interventions

DRUG

TNX-102 SL

Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks

DRUG

Placebo SL Tablet

Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Greg Sullivan, MD · Tonix Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-27
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 NCT03062540 on ClinicalTrials.gov