Clinical trial NCT03841773: A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
Official title: A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: PTSD
Keywords: PTSD
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 192
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 TNX-102 SL 5.6 mg (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 and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
* Index trauma must have occurred within 9 years of Screening Visit
* Must have occurred when the patient was ≥18 years of age

Exclusion Criteria:

* Use of antidepressant medication within 2 months of Baseline

Primary outcomes:
measure: Mean Change From Baseline in the Total CAPS-5 Score
timeFrame: Day 1, Week 12
Secondary outcomes:
measure: Clinical Global Impression of Severity (CGI-S)
timeFrame: Day 1, Week 12
measure: Sheehan Disability Scale (SDS)
timeFrame: Day 1, Week 12
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance
timeFrame: Day 1, Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Ashild Peters
state: Arizona
city: Little Rock
country: United States
facility: Ashild Peters
state: Arkansas
city: Rogers
country: United States
facility: Ashild Peters
state: Arkansas
city: Beverly Hills
country: United States
facility: Ashild Peters
state: California
city: Oceanside
country: United States
facility: Ashild Peters
state: California
city: Orange
country: United States
facility: Ashild Peters
state: California
city: Panorama City
country: United States
facility: Ashild Peters
state: California
city: Riverside
country: United States
facility: Ashild Peters
state: California
city: San Diego
country: United States
facility: Ashild Peters
state: California
city: Temecula
country: United States
facility: Ashild Peters
state: California
city: Colorado Springs
country: United States
facility: Ashild Peters
state: Colorado
city: Norwich
country: United States
facility: Ashild Peters
state: Connecticut
city: Washington
country: United States
facility: Ashild Peters
state: District of Columbia
city: Jacksonville
country: United States
facility: Ashild Peters
state: Florida
city: North Miami
country: United States
facility: Ashild Peters
state: Florida
city: Orlando
country: United States
facility: Ashild Peters
state: Florida
city: Tampa
country: United States
facility: Ashild Peters
state: Florida
city: Alpharetta
country: United States
facility: Ashild Peters
state: Georgia
city: Lincolnwood
country: United States
facility: Ashild Peters
state: Illinois
city: Boston
country: United States
facility: Ashild Peters
state: Massachusetts
city: New Bedford
country: United States
facility: Ashild Peters
state: Massachusetts
city: Flowood
country: United States
facility: Ashild Peters
state: Mississippi
city: Saint Louis
country: United States
facility: Ashild Peters
state: Missouri
city: Las Vegas
country: United States
facility: Ashild Peters
state: Nevada
city: Oklahoma City
country: United States
facility: Ashild Peters
state: Oklahoma
city: Portland
country: United States
facility: Ashild Peters
state: Oregon
city: Salem
country: United States
facility: Ashild Peters
state: Oregon
city: Memphis
country: United States
facility: Ashild Peters
state: Tennessee
city: Austin
country: United States
facility: Ashild Peters
state: Texas
city: Dallas
country: United States
facility: Ashild Peters
state: Texas
Study officials:
affiliation: Tonix Pharmaceuticals
name: Gregory M Sullivan, MD
role: STUDY_DIRECTOR
References: