Status:
COMPLETED
Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Conditions:
PTSD
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT02277704
Start Date
October 1 2014
End Date
May 1 2016
Last Update
June 20 2024
Active Locations (23)
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1
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States, 35404
2
Noesis Pharma
Phoenix, Arizona, United States, 85032
3
Sun Valley Research Center
Imperial, California, United States, 92251
4
National City
National City, California, United States, 91950