Clinical trial NCT03062540: Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: PTSD
Keywords: PTSD
Military-related PTSD
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2017-02-23
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.
timeFrame: Day 0 and Week 12
Secondary outcomes:
measure: Clinical Global Impression - Improvement From Initiation of Treatment (CGI-I) Score After 12 Weeks of Treatment.
timeFrame: Week 12
measure: Change From Baseline in the Disruption of Social Life/Leisure Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.
timeFrame: Day 0, Week 12.
measure: Change From Baseline in the Disruption of Work/School Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.
timeFrame: Day 0, Week 12.
measure: 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.
timeFrame: Day 0, Week 12.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix
state: Arizona
city: Little Rock
country: United States
facility: Little Rock
state: Arkansas
city: Rogers
country: United States
facility: Rogers
state: Arkansas
city: Beverly Hills
country: United States
facility: Beverly hills
state: California
city: Glendale
country: United States
facility: Glendale
state: California
city: Oakland
country: United States
facility: Oakland
state: California
city: Oceanside
country: United States
facility: Oceanside
state: California
city: Orange
country: United States
facility: Orange
state: California
city: Riverside
country: United States
facility: Riverside
state: California
city: San Diego
country: United States
facility: San Diego
state: California
city: San Diego
country: United States
facility: San Diego
state: California
city: Temecula
country: United States
facility: Temecula
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs
state: Colorado
city: Cromwell
country: United States
facility: Cromwell
state: Connecticut
city: Norwich
country: United States
facility: Norwich
state: Connecticut
city: Washington
country: United States
facility: Washington, D.C.
state: District of Columbia
city: Jacksonville
country: United States
facility: Jacksonville
state: Florida
city: Lake City
country: United States
facility: Lake City
state: Florida
city: Lauderhill
country: United States
facility: Lauderhill
state: Florida
city: Maitland
country: United States
facility: Maitland
state: Florida
city: Tampa
country: United States
facility: Tampa
state: Florida
city: Atlanta
country: United States
facility: Atlanta
state: Georgia
city: Chicago
country: United States
facility: Chicago
state: Illinois
city: New Bedford
country: United States
facility: New Bedford
state: Massachusetts
city: Flowood
country: United States
facility: Flowood
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis
state: Missouri
city: Missoula
country: United States
facility: Missoula
state: Montana
city: Las Vegas
country: United States
facility: Las Vegas
state: Nevada
city: Berlin
country: United States
facility: Berlin
state: New Jersey
city: Cedarhurst
country: United States
facility: Cedarhurst
state: New York
city: New York
country: United States
facility: New York
state: New York
city: Canton
country: United States
facility: Canton
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati
state: Ohio
city: Dayton
country: United States
facility: Dayton
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City
state: Oklahoma
city: Downingtown
country: United States
facility: Downingtown
state: Pennsylvania
city: Media
country: United States
facility: Media
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston
state: South Carolina
city: Austin
country: United States
facility: Austin
state: Texas
city: Dallas
country: United States
facility: Dallas
state: Texas
city: Houston
country: United States
facility: Houston
state: Texas
city: San Antonio
country: United States
facility: San Antonio
state: Texas
city: Salem
country: United States
facility: Salem
state: Virginia
city: Everett
country: United States
facility: Everett
state: Washington
Study officials:
affiliation: Tonix Pharmaceuticals
name: Greg Sullivan, MD
role: STUDY_DIRECTOR
References:
citation: Parmenter ME, Lederman S, Weathers FW, Davis LL, Vaughn B, Engels J, Sullivan GM. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder. Psychiatry Res. 2024 Apr;334:115764. doi: 10.1016/j.psychres.2024.115764. Epub 2024 Feb 1.
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.