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

Tonix Pharmaceuticals, Inc.245 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

245

Conditions

PTSD

Interventions

TNX-102 SLDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (23)

Tuscaloosa VA Medical Center

Tuscaloosa, Alabama, United States

Outcomes

Primary Outcomes

The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).

The mean change from baseline (Visit 2) in the Total CAPS-5 score after 12 weeks of treatment evaluated at Visit 9 (Week 12). The primary efficacy comparison will be the change from baseline in total CAPS-5 score for the 2.8 mg treatment arm compared to placebo. CAPS-5 score ranges from 0-80 with lower scores indicating less severe PTSD symptoms.

Time frame: Day 1, Week 12

Secondary Outcomes

Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment

Change from baseline in patients' quality of sleep using the PROMIS (Patient -Reported Outcome Measurement Information System) Sleep Disturbance scale after 12 weeks of treatment comparing the 2.8 mg treatment arm to placebo. Raw scores are converted to T-scores using published conversion tables. Sleep Disturbance T-score ranges from 28.9 to 76.5. Lower scores indicate less sleep disturbance

Time frame: Day 1, Week 12

Clinician Global Impression - Improvement Scale Responder Rate at Week 12

Responder rates in CGI-I (Clinician Global Impression - Improvement Scale) after 12 weeks of treatment comparing the 2.8 mg treatment arm to placebo. Responder rate is defined as the number of patients scored as either a 1 or 2 on CGI-I at Week 12. The score ranges from 1 to 7 with the following anchors for each score:1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse

Time frame: Week 12

Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score

Mean Change from Baseline in SDS Total Score at Week 12. Score ranges from 0 to 30. A score of 0 means the patient is unimpaired, and a score of 30 means the patient is highly impaired.

Time frame: Day 1, Week 12

Data from ClinicalTrials.gov

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