A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
NCT ID: NCT02589275
Last Updated: 2025-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
375 participants
INTERVENTIONAL
2015-08-04
2016-09-28
Brief Summary
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Patients will not be made aware of the therapy they received during the double-blind study.
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Detailed Description
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Primary:
The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 3 months in patients with FM who have completed the double-blinded lead-in study
Secondary:
The secondary objective is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of FM
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 Tablet 2.8 mg
1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months
TNX-102 SL Tablet 2.8 mg
TNX-102 SL 2.8 mg tablet taken daily at bedtime
Interventions
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TNX-102 SL Tablet 2.8 mg
TNX-102 SL 2.8 mg tablet taken daily at bedtime
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient completed expected dosing in F301 or F302 defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the F301 or F302 lead-in study) and no major protocol deviations.
* The patient has provided written informed consent to participate in this extension protocol.
Exclusion Criteria
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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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Sacramento, California, United States
San Diego, California, United States
Brandon, Florida, United States
DeLand, Florida, United States
Lakeland, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Columbus, Georgia, United States
Smyrna, Georgia, United States
Evansville, Indiana, United States
North Dartmouth, Massachusetts, United States
Ann Arbor, Michigan, United States
Jackson, Mississippi, United States
Williamsville, New York, United States
Cincinnati, Ohio, United States
Middleburg Heights, Ohio, United States
Medford, Oregon, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Warwick, Rhode Island, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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TNX-CY-F303
Identifier Type: -
Identifier Source: org_study_id
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