Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
NCT ID: NCT02277704
Last Updated: 2024-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
245 participants
INTERVENTIONAL
2014-10-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
Placebo
TNX-102 SL, 2.8 mg
1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
TNX-102 SL
Placebo
TNX-102 SL, 5.6 mg
2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
TNX-102 SL
Interventions
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TNX-102 SL
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Tonix Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Denise Bedoya
Role: STUDY_DIRECTOR
Premier Research Group plc
Locations
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Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States
Noesis Pharma
Phoenix, Arizona, United States
Sun Valley Research Center
Imperial, California, United States
National City
National City, California, United States
Excell Research, Inc
Oceanside, California, United States
Neuropsychiatric Research Center of Orange County
Orange, California, United States
CITRIALS
Riverside, California, United States
Veteran Affairs, San Diego Health Care System
San Diego, California, United States
Cns, Inc.
Torrance, California, United States
Sarkis Clinical Trials
Lake City, Florida, United States
Compass Research North, LLC
Leesburg, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Atlanta Center For Medical Research
Atlanta, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Novex Clinical Research
New Bedford, Massachusetts, United States
Premier Psychiatric Research Institute, Inc.
Lincoln, Nebraska, United States
Altea Research
Las Vegas, Nevada, United States
Cedarhurst
Cedarhurst, New York, United States
Cincinnati
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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References
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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.
Other Identifiers
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TNX-CY-P201
Identifier Type: -
Identifier Source: org_study_id
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