Clinical Trials Logo
  1. Home
  2. PTSD
  3. NCT03841773

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD — RECOVERY  

PTSD Clinical Trial

Official title:
A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)

Clinical Trial Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03841773
Study type Interventional
Source Tonix Pharmaceuticals, Inc.
Contact
Status Terminated
Phase Phase 3
Start date March 7, 2019
Completion date April 24, 2020
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03962504 - Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial N/A
Completed NCT01995123 - Behavioral Activation for Smoking Cessation in PTSD N/A
Not yet recruiting NCT06278922 - Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma N/A
Completed NCT04597450 - Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT03593772 - Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD N/A
Completed NCT03429166 - Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas N/A
Recruiting NCT04317820 - Deep Brain Reorienting in Post-traumatic Stress Disorder N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT03504722 - Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD N/A
Completed NCT04305353 - Intensive Care Unit (ICU) Diary Project N/A
Completed NCT03113890 - McLean and Genomind Prospective Study N/A
Withdrawn NCT05173831 - Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans Phase 2
Withdrawn NCT03924297 - Chilipad for Sleep and Symptoms of PTSD N/A
Not yet recruiting NCT04056767 - Changes in Digital Phenotype During PE Therapy
Withdrawn NCT03216356 - Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD Phase 2/Phase 3
Completed NCT03343028 - Biomarker Establishment for Superior Treatment of PTSD
Completed NCT03158558 - Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD N/A
Completed NCT02370173 - A Non-Pharmacological Method for Enhancing Sleep in PTSD N/A
Withdrawn NCT01957371 - Mindful Yoga Therapy for Veterans With PTSD and Pain N/A
Completed NCT01955538 - The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees. Phase 3