Overview

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

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
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