search
Back to results

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

Primary Purpose

PTSD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TNX-102 SL
Placebo
Sponsored by
Tonix Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Military-related PTSD and other related conditions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tuscaloosa VA Medical Center
  • Noesis Pharma
  • Sun Valley Reserach Center
  • National City
  • Excell Research, Inc
  • Neuropsychiatric Research Center of Orange County
  • CITRIALS
  • Vetern Affairs, San Diego Health Care System
  • Cns, Inc.
  • Sarkis Clinical Trials
  • Compass Research North, LLC
  • Clinical Neuroscience Solutions, Inc.
  • Atlanta Center For Medical Research
  • Great Lakes Clinical Trials
  • Novex Clinical Research
  • Premier Psychiatric Research Instititute, Inc.
  • Altea Research
  • Cedarhurst
  • Cincinnati
  • University Hospitals Case Medical Center
  • IPS Research Company
  • Clinical Trials of Texas
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Treatment A

Treatment B

Treatment C

Arm Description

2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.

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.

2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.

Outcomes

Primary Outcome Measures

Evaluate the efficacy of TNX-102 SL 2.8 mg using the DSM-5 total symptom severity score
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.

Secondary Outcome Measures

Clinician Administered PTSD Scale (for DSM-5)
PTSD Checklist (Version 5)
Sheehan Disability Scale
Patient Global Impression of Change (Since Baseline) Scale
Number of Participants with Adverse Events
Change from baseline in ECG, lab results, vital signs and weight
Changes from baseline in subject reported morning sedation
Changes from baseline indicative of increased suicidal ideation or behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Patient-Reported Outcome Measurement Information System- Sleep

Full Information

First Posted
October 23, 2014
Last Updated
October 26, 2017
Sponsor
Tonix Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02277704
Brief Title
Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
Acronym
AtEase
Official Title
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"
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tonix Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, Military-related PTSD and other related conditions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Placebo Comparator
Arm Description
2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
Arm Title
Treatment B
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment C
Arm Type
Active Comparator
Arm Description
2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
Intervention Type
Drug
Intervention Name(s)
TNX-102 SL
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Evaluate the efficacy of TNX-102 SL 2.8 mg using the DSM-5 total symptom severity score
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (for DSM-5)
Time Frame
Continuously throughout the treatment period (total duration: about 3 months)
Title
PTSD Checklist (Version 5)
Time Frame
Continuously throughout the treatment period (total duration: about 3 months)
Title
Sheehan Disability Scale
Time Frame
Continuously throughout the treatment period (total duration: about 3 months)
Title
Patient Global Impression of Change (Since Baseline) Scale
Time Frame
Continuously throughout the treatment period (total duration: about 3 months)
Title
Number of Participants with Adverse Events
Time Frame
Continuously throughout the treatment period (total duration: about 3 months)
Title
Change from baseline in ECG, lab results, vital signs and weight
Time Frame
Baseline and week 12
Title
Changes from baseline in subject reported morning sedation
Time Frame
Baseline, and weeks 2, 4, 8, and 12
Title
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
Title
Patient-Reported Outcome Measurement Information System- Sleep
Time Frame
Continuously throughout the treatment period (total duration: about 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Bedoya
Organizational Affiliation
Premier Research Group plc
Official's Role
Study Director
Facility Information:
Facility Name
Tuscaloosa VA Medical Center
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States
Facility Name
Noesis Pharma
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Sun Valley Reserach Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
National City
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Excell Research, Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
CITRIALS
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Vetern Affairs, San Diego Health Care System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Cns, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Sarkis Clinical Trials
City
Lake City
State/Province
Florida
ZIP/Postal Code
32025
Country
United States
Facility Name
Compass Research North, LLC
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Atlanta Center For Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Novex Clinical Research
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Premier Psychiatric Research Instititute, Inc.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Altea Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Cedarhurst
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33979763
Citation
Sullivan GM, Gendreau RM, Gendreau J, Peters P, Peters A, Engels J, Daugherty BL, Vaughn B, Weathers FW, Lederman S. Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response. Psychiatry Res. 2021 Jul;301:113974. doi: 10.1016/j.psychres.2021.113974. Epub 2021 Apr 30.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs