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

A 12-Week Open-Label Extension Study to Evaluate TNX-102 SL Taken Daily at Bedtime in Patients With PTSD

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.

Study Overview

• Status: Terminated
• Conditions: PTSD
• Intervention / Treatment: Drug: TNX-102 SL

Detailed Description

The study will consist of 5 study visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit on double-blind treatment), a phone visit after 2 weeks of treatment, and in-clinic visits after 4, 8, and 12 weeks of treatment.

The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.

The secondary objective of the study is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Phoenix
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Rogers
  • California
    • Beverly Hills, California, United States, 90210
      • Beverly Hills
    • Glendale, California, United States, 91206
      • Glendale
    • Oakland, California, United States, 94607
      • Oakland
    • Oceanside, California, United States, 92056
      • Oceanside
    • Orange, California, United States, 92868
      • Orange
    • Riverside, California, United States, 92506
      • Riverside
    • San Diego, California, United States, 92123
      • San Diego
    • San Diego, California, United States, 92161
      • San Diego
    • Temecula, California, United States, 92591
      • Temecula
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Colorado Springs
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Jacksonville
    • Lake City, Florida, United States, 32607
      • Lake City
    • Lauderhill, Florida, United States, 33319
      • Lauderhill
    • Tampa, Florida, United States, 33609
      • Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30341
      • Atlanta
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • New Bedford
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Flowood
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Las Vegas
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Berlin
  • New York
    • Cedarhurst, New York, United States, 11516
      • Cedarhurst
    • New York, New York, United States, 10128
      • New York
  • Ohio
    • Canton, Ohio, United States, 44718
      • Canton
    • Cincinnati, Ohio, United States, 45219
      • Cincinnati
    • Dayton, Ohio, United States, 45417
      • Dayton
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Oklahoma City
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Charleston
  • Texas
    • Austin, Texas, United States, 78754
      • Austin
    • Dallas, Texas, United States, 75231
      • Dallas
    • Houston, Texas, United States, 77098
      • Houston
    • San Antonio, Texas, United States, 78229
      • San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient has completed the final treatment study visit of the lead-in study and remained compliant with the lead-in protocol and study treatment.
• The patient has provided written informed consent to participate in this extension protocol.
• Female patients of childbearing potential continue to agree to practice one of the medically acceptable methods of birth control detailed in the lead-in study.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TNX-102 SL; 2 x TNX-102 SL, 2.8 mg tablets taken daily at bedtime for 12 weeks	Drug: TNX-102 SL; 2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks; Other Names: cyclobenzaprine HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the incidence of adverse events of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study	Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the change from both baselines in the Total CAPS-5 score of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study	The CAPS-5 symptom severity 1-week recall version will be administered by qualified and trained clinicians.	Week 0, 12
Evaluate the proportion of patients with a CGI-I score of "very much improved" or "much improved" of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study	The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline.	Week 4, 8, 12

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.
• Collaborators: Premier Research Group plc

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2017
• Primary Completion (ACTUAL): July 27, 2018
• Study Completion (ACTUAL): July 27, 2018

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: PTSD; Safety; Efficacy; Sublingual; TNX-102 SL; Bedtime; 3-month
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Tricyclic; Neuromuscular Agents; Muscle Relaxants, Central; Cyclobenzaprine
• Other Study ID Numbers: TNX-CY-P303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No