Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
NCT ID: NCT03062540
Last Updated: 2024-05-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
358 participants
INTERVENTIONAL
2017-03-27
2018-07-27
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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TNX-102 SL Tablet, 5.6 mg
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
Placebo SL Tablet
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
Interventions
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TNX-102 SL
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
Placebo SL Tablet
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5.
* Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.
* Willing to refrain from use of all other formulations of cyclobenzaprine.
* Willing and able to refrain from antidepressants and other excluded medications.
* Capable of reading and understanding English and able to provide written informed consent.
* If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
* Willing and able to comply with all protocol-specified requirements.
Exclusion Criteria
* Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.
* Severe depressive symptoms at screening or baseline.
* Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
* Use of antidepressant medication within 2 months of baseline.
* Female patients who are pregnant or lactating.
* History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
* Seizure disorder.
* Patients with a body mass index (BMI) \> 45.
* Has received any other investigational drug within 30 days before Screening.
* Previous participation in any other study with TNX-102 SL.
* Family member of investigative staff.
18 Years
75 Years
ALL
No
Sponsors
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Premier Research Group plc
UNKNOWN
Tonix Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Greg Sullivan, MD
Role: STUDY_DIRECTOR
Tonix Pharmaceuticals
Locations
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Phoenix
Phoenix, Arizona, United States
Little Rock
Little Rock, Arkansas, United States
Rogers
Rogers, Arkansas, United States
Beverly hills
Beverly Hills, California, United States
Glendale
Glendale, California, United States
Oakland
Oakland, California, United States
Oceanside
Oceanside, California, United States
Orange
Orange, California, United States
Riverside
Riverside, California, United States
San Diego
San Diego, California, United States
San Diego
San Diego, California, United States
Temecula
Temecula, California, United States
Colorado Springs
Colorado Springs, Colorado, United States
Cromwell
Cromwell, Connecticut, United States
Norwich
Norwich, Connecticut, United States
Washington, D.C.
Washington D.C., District of Columbia, United States
Jacksonville
Jacksonville, Florida, United States
Lake City
Lake City, Florida, United States
Lauderhill
Lauderhill, Florida, United States
Maitland
Maitland, Florida, United States
Tampa
Tampa, Florida, United States
Atlanta
Atlanta, Georgia, United States
Chicago
Chicago, Illinois, United States
New Bedford
New Bedford, Massachusetts, United States
Flowood
Flowood, Mississippi, United States
St. Louis
St Louis, Missouri, United States
Missoula
Missoula, Montana, United States
Las Vegas
Las Vegas, Nevada, United States
Berlin
Berlin, New Jersey, United States
Cedarhurst
Cedarhurst, New York, United States
New York
New York, New York, United States
Canton
Canton, Ohio, United States
Cincinnati
Cincinnati, Ohio, United States
Dayton
Dayton, Ohio, United States
Oklahoma City
Oklahoma City, Oklahoma, United States
Downingtown
Downingtown, Pennsylvania, United States
Media
Media, Pennsylvania, United States
Charleston
Charleston, South Carolina, United States
Austin
Austin, Texas, United States
Dallas
Dallas, Texas, United States
Houston
Houston, Texas, United States
San Antonio
San Antonio, Texas, United States
Salem
Salem, Virginia, United States
Everett
Everett, Washington, United States
Countries
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References
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Parmenter ME, Lederman S, Weathers FW, Davis LL, Vaughn B, Engels J, Sullivan GM. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder. Psychiatry Res. 2024 Apr;334:115764. doi: 10.1016/j.psychres.2024.115764. Epub 2024 Feb 1.
Dunlop BW, Rakofsky JJ, Newport DJ, Mletzko-Crowe T, Barone K, Nemeroff CB, Harvey PD. Efficacy of Vortioxetine Monotherapy for Posttraumatic Stress Disorder: A Randomized, Placebo-Controlled Trial. J Clin Psychopharmacol. 2021 Mar-Apr 01;41(2):172-179. doi: 10.1097/JCP.0000000000001363.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TNX-CY-P301
Identifier Type: -
Identifier Source: org_study_id
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