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Safety and Efficacy Study of TNX-102 SL in Participants With PTSD

NCT05372887 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-12-11

No results posted yet for this study

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 1 for 12 weeks

DRUG

Placebo

Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory 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
2022-10-14
Primary Completion
2022-11-08
Completion
2022-11-08
FDA Drug
Yes

Countries

  • Kenya

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 NCT05372887 on ClinicalTrials.gov