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

October 26, 2017 updated by: Tonix Pharmaceuticals, Inc.

A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken at Bedtime in Subjects With Military-Related PTSD and Related Conditions (Protocol No. TNX-CY-P201) -"AtEase STUDY"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

247

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35404
        • Tuscaloosa VA Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Noesis Pharma
    • California
      • Imperial, California, United States, 92251
        • Sun Valley Reserach Center
      • National City, California, United States, 91950
        • National City
      • Oceanside, California, United States, 92506
        • Excell Research, Inc
      • Orange, California, United States, 92868
        • Neuropsychiatric Research Center of Orange County
      • Riverside, California, United States, 92506
        • CiTrials
      • San Diego, California, United States, 92161
        • Vetern Affairs, San Diego Health Care System
      • Torrance, California, United States, 90502
        • CNS, Inc.
    • Florida
      • Lake City, Florida, United States, 32025
        • Sarkis Clinical Trials
      • Leesburg, Florida, United States, 34748
        • Compass Research North, LLC
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Novex Clinical Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Premier Psychiatric Research Instititute, Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Altea Research
    • New York
      • Cedarhurst, New York, United States, 11516
        • Cedarhurst
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female between 18 and 65 years of age
  • Diagnosed with current PTSD as defined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5),
  • For patients with a qualifying Index trauma(s) resulting in PTSD that occurred during military service, military contractor, Department of Homeland Security or law enforcement
  • Willing and able to withdraw and refrain from specific therapies (ask PI)
  • Use medically acceptable form of contraception (female only)
  • Signed informed consent

Exclusion Criteria:

  • Significant traumatic brain injury
  • Severe depression
  • Bipolar and psychotic disorders
  • Increase risk of suicide
  • Significant clinical (cardiac, systemic infection, drug/alcohol abuse) or laboratory abnormalities (including positivity for Hep B, Hep C, HIV)
  • Unable to wash-out specific medications (ask PI)
  • History of violent behavior within past 2 years, unrelated to work duties
  • History of drug or alcohol abuse within past 6 months
  • Positive illegal substance test
  • Known hypersensitivity to cyclobenzaprine
  • Others: seizure disorders, uncontrolled sleep apnea, BMI>40
  • Participation in an investigational study in past 30 days
  • In the process of litigating for compensation for a psychiatric disorder
  • Females that are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Treatment A
2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
Drug: Placebo
Active Comparator: Treatment B
1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
Drug: Placebo
Drug: TNX-102 SL
Active Comparator: Treatment C
2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
Drug: TNX-102 SL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the efficacy of TNX-102 SL 2.8 mg using the DSM-5 total symptom severity score
Time Frame: 12 weeks
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study.
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinician Administered PTSD Scale (for DSM-5)
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
Continuously throughout the treatment period (total duration: about 3 months)
PTSD Checklist (Version 5)
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
Continuously throughout the treatment period (total duration: about 3 months)
Sheehan Disability Scale
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
Continuously throughout the treatment period (total duration: about 3 months)
Patient Global Impression of Change (Since Baseline) Scale
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
Continuously throughout the treatment period (total duration: about 3 months)
Number of Participants with Adverse Events
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
Continuously throughout the treatment period (total duration: about 3 months)
Change from baseline in ECG, lab results, vital signs and weight
Time Frame: Baseline and week 12
Baseline and week 12
Changes from baseline in subject reported morning sedation
Time Frame: Baseline, and weeks 2, 4, 8, and 12
Baseline, and weeks 2, 4, 8, and 12
Changes from baseline indicative of increased suicidal ideation or behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline, and weeks 1, 2, 4, 6, 8, and 12
Baseline, and weeks 1, 2, 4, 6, 8, and 12
Patient-Reported Outcome Measurement Information System- Sleep
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
Continuously throughout the treatment period (total duration: about 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tonix Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNX-CY-P201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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