Clinical trial NCT02277704: Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: PTSD
Keywords: PTSD
Military-related PTSD and other related conditions
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-29
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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, 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.


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

Primary outcomes:
measure: The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).
timeFrame: Day 1, Week 12
Secondary outcomes:
measure: Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment
timeFrame: Day 1, Week 12
measure: Clinician Global Impression - Improvement Scale Responder Rate at Week 12
timeFrame: Week 12
measure: Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score
timeFrame: Day 1, Week 12
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Noesis Pharma
state: Arizona
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: National City
country: United States
facility: National City
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Riverside
country: United States
facility: CITRIALS
state: California
city: San Diego
country: United States
facility: Veteran Affairs, San Diego Health Care System
state: California
city: Torrance
country: United States
facility: Cns, Inc.
state: California
city: Lake City
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Leesburg
country: United States
facility: Compass Research North, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center For Medical Research
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: New Bedford
country: United States
facility: Novex Clinical Research
state: Massachusetts
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Cedarhurst
country: United States
facility: Cedarhurst
state: New York
city: Cincinnati
country: United States
facility: Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Premier Research Group plc
name: Denise Bedoya
role: STUDY_DIRECTOR
References:
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.