search
Back to results

Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD (HONOR)

Primary Purpose

PTSD

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TNX-102 SL
Placebo SL Tablet
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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female between 18 and 75 years of age, who have served in any branch of the military.
  • Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5.
  • Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.
  • Willing to refrain from use of all other formulations of cyclobenzaprine.
  • Willing and able to refrain from antidepressants and other excluded medications.
  • Capable of reading and understanding English and able to provide written informed consent.
  • If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
  • Willing and able to comply with all protocol-specified requirements.

Exclusion Criteria:

  • Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.
  • Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.
  • Severe depressive symptoms at screening or baseline.
  • Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
  • Use of antidepressant medication within 2 months of baseline.
  • Female patients who are pregnant or lactating.
  • History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
  • Seizure disorder.
  • Patients with a body mass index (BMI) > 45.
  • Has received any other investigational drug within 30 days before Screening.
  • Previous participation in any other study with TNX-102 SL.
  • Family member of investigative staff.

Sites / Locations

  • Phoenix
  • Little Rock
  • Rogers
  • Beverly hills
  • Glendale
  • Oakland
  • Oceanside
  • Orange
  • Riverside
  • San Diego
  • San Diego
  • Temecula
  • Colorado Springs
  • Cromwell
  • Norwich
  • Washington, D.C.
  • Jacksonville
  • Lake City
  • Lauderhill
  • Maitland
  • Tampa
  • Atlanta
  • Chicago
  • New Bedford
  • Flowood
  • St. Louis
  • Missoula
  • Las Vegas
  • Berlin
  • Cedarhurst
  • New York
  • Canton
  • Cincinnati
  • Dayton
  • Oklahoma City
  • Downingtown
  • Media
  • Charleston
  • Austin
  • Dallas
  • Houston
  • Salem
  • Everett

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TNX-102 SL Tablet, 2.8 mg

Placebo SL Tablet

Arm Description

2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.

2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.

Outcomes

Primary Outcome Measures

Mean change from baseline in the total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.
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

Clinical Global Impression - Improvement from Initiation of Treatment (CGI-I) score after 12 weeks of treatment.
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the CGI-I score after 12 weeks of treatment.
Change from baseline in the disruption of social life/leisure activities assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of social life/leisure activities assessed with the SDS after 12 weeks of treatment.
Change from baseline in the disruption of work/school activities assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of work/school activities assessed with the SDS after 12 weeks of treatment.
Change from baseline in patients' quality of sleep using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance scale after 12 weeks of treatment.
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in quality of sleep using the PROMIS Sleep Disturbance scale after 12 weeks of treatment.

Full Information

First Posted
February 20, 2017
Last Updated
September 9, 2019
Sponsor
Tonix Pharmaceuticals, Inc.
Collaborators
Premier Research Group plc
search

1. Study Identification

Unique Protocol Identification Number
NCT03062540
Brief Title
Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
Acronym
HONOR
Official Title
A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients With Military-Related PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Stopped early due to inadequate separation on primary efficacy endpoint at Week 12 according to Interim Analysis conducted on the first 274 (50%) patients.
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
July 27, 2018 (Actual)
Study Completion Date
July 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tonix Pharmaceuticals, Inc.
Collaborators
Premier Research Group plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
358 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNX-102 SL Tablet, 2.8 mg
Arm Type
Experimental
Arm Description
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
Arm Title
Placebo SL Tablet
Arm Type
Placebo Comparator
Arm Description
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TNX-102 SL
Other Intervention Name(s)
Low dose cyclobenzaprine sublingual tablets
Intervention Description
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo SL Tablet
Other Intervention Name(s)
Placebo sublingual tablets
Intervention Description
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
Primary Outcome Measure Information:
Title
Mean change from baseline in the total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.
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
Day 0, Week 4, Week 8 and Week 12
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Improvement from Initiation of Treatment (CGI-I) score after 12 weeks of treatment.
Description
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the CGI-I score after 12 weeks of treatment.
Time Frame
12 weeks
Title
Change from baseline in the disruption of social life/leisure activities assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.
Description
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of social life/leisure activities assessed with the SDS after 12 weeks of treatment.
Time Frame
Day 0, Week 4, Week 8 and Week 12.
Title
Change from baseline in the disruption of work/school activities assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.
Description
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of work/school activities assessed with the SDS after 12 weeks of treatment.
Time Frame
Day 0, Week 4, Week 8 and Week 12.
Title
Change from baseline in patients' quality of sleep using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance scale after 12 weeks of treatment.
Description
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in quality of sleep using the PROMIS Sleep Disturbance scale after 12 weeks of treatment.
Time Frame
Day 0, Week 4, Week 8 and Week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female between 18 and 75 years of age, who have served in any branch of the military. Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5. Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related. Willing to refrain from use of all other formulations of cyclobenzaprine. Willing and able to refrain from antidepressants and other excluded medications. Capable of reading and understanding English and able to provide written informed consent. If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study. Willing and able to comply with all protocol-specified requirements. Exclusion Criteria: Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol. Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history. Severe depressive symptoms at screening or baseline. Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion. Use of antidepressant medication within 2 months of baseline. Female patients who are pregnant or lactating. History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients. Seizure disorder. Patients with a body mass index (BMI) > 45. Has received any other investigational drug within 30 days before Screening. Previous participation in any other study with TNX-102 SL. Family member of investigative staff.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Sullivan, MD
Organizational Affiliation
Tonix Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Little Rock
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Rogers
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Beverly hills
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Glendale
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Oceanside
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Temecula
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Cromwell
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Norwich
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Washington, D.C.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20018
Country
United States
Facility Name
Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Lake City
City
Lake City
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Lauderhill
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Maitland
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
New Bedford
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Flowood
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Missoula
City
Missoula
State/Province
Montana
ZIP/Postal Code
59812
Country
United States
Facility Name
Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Berlin
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Cedarhurst
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
New York
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Canton
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Downingtown
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Media
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Salem
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33587394
Citation
Dunlop BW, Rakofsky JJ, Newport DJ, Mletzko-Crowe T, Barone K, Nemeroff CB, Harvey PD. Efficacy of Vortioxetine Monotherapy for Posttraumatic Stress Disorder: A Randomized, Placebo-Controlled Trial. J Clin Psychopharmacol. 2021 Mar-Apr 01;41(2):172-179. doi: 10.1097/JCP.0000000000001363.
Results Reference
derived

Learn more about this trial

Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

We'll reach out to this number within 24 hrs