12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
NCT ID: NCT03110575
Last Updated: 2025-02-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
190 participants
INTERVENTIONAL
2017-06-20
2018-07-27
Brief Summary
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Detailed Description
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The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.
The secondary objective of the study is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.
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
2 x TNX-102 SL, 2.8 mg tablets taken daily at bedtime for 12 weeks
TNX-102 SL
2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks
Interventions
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TNX-102 SL
2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient has provided written informed consent to participate in this extension protocol.
* 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.
Exclusion Criteria
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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Denise Bedoya
Role: STUDY_DIRECTOR
Premier Research Group plc
Locations
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Phoenix
Phoenix, Arizona, 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
Jacksonville
Jacksonville, Florida, United States
Lake City
Lake City, Florida, United States
Lauderhill
Lauderhill, Florida, United States
Tampa
Tampa, Florida, United States
Atlanta
Atlanta, Georgia, United States
New Bedford
New Bedford, Massachusetts, United States
Flowood
Flowood, Mississippi, 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
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
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-P303
Identifier Type: -
Identifier Source: org_study_id
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