A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
NCT ID: NCT03508700
Last Updated: 2025-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
93 participants
INTERVENTIONAL
2018-04-19
2019-09-30
Brief Summary
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Detailed Description
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The study will consist of 5 in-clinic study visits, including Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit of the 12-week open-label extension study TNX-CY-P303), followed by in-clinic visits after 7, 16, 28 and 40 weeks of open-label treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TNX-102 SL 5.6 mg
2 tablets of TNX-102 SL 2.8 mg taken simultaneously and sublingually (under the tongue) each day at bedtime starting on Day 0 for 40 weeks
TNX-102 SL 5.6 mg
cyclobenzaprine HCl sublingual tablets
Interventions
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TNX-102 SL 5.6 mg
cyclobenzaprine HCl sublingual tablets
Eligibility Criteria
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Inclusion Criteria
* The patient has provided written informed consent to participate in this extension study.
* The patient met all prior inclusion and exclusion requirements for the double-blind lead-in HONOR study, or the site received medical monitor approval for the patient to remain in the lead-in study after the retrospective discovery of an entry violation that did not pose any threat to the patient's safety or well-being.
* During the course of the lead-in HONOR study or 12-week open-label extension P303 study, the patient has had no intervening medical conditions including pregnancy, clinically significant increase in suicidal ideation (plan or intent) or significant worsening of depression, newly arising clinically significant abnormal laboratory tests, or any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the patient's ability to participate in the study or potentially compromise the patient's well-being during the study.
* The patient does not require treatment with a potent (strong) cytochrome P450 subtype 3A4 (CYP3A4) inhibitor, or St. John's wort.
* The patient is willing to refrain from use of all other formulations of cyclobenzaprine for the duration of the study.
* The patient is willing to refrain from use of monoamine oxidase inhibitors for the duration of the study.
* Female patients of childbearing potential continue to agree to practice one of the medically acceptable methods of birth control detailed in the lead-in study.
18 Years
75 Years
ALL
No
Sponsors
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Tonix Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Little Rock
Little Rock, Arkansas, United States
Beverly Hills
Beverly Hills, California, United States
Oceanside
Oceanside, California, United States
Orange
Orange, California, United States
Temecula
Temecula, California, United States
Colorado Springs
Colorado Springs, Colorado, United States
Norwich
Norwich, Connecticut, United States
Tampa
Tampa, Florida, United States
Atlanta
Atlanta, Georgia, United States
New Bedford
New Bedford, Massachusetts, United States
Las Vegas
Las Vegas, Nevada, 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
Oklahoma City
Oklahoma City, Oklahoma, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TNX-CY-P306
Identifier Type: -
Identifier Source: org_study_id
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