A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia
NCT ID: NCT02436096
Last Updated: 2025-02-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
519 participants
INTERVENTIONAL
2015-04-30
2016-09-30
Brief Summary
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The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.
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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, 2.8 mg
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
Placebo SL Tablet
1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks
Placebo SL Tablet
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
Interventions
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TNX-102 SL Tablet, 2.8mg
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
Placebo SL Tablet
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female 18-75 years old
* For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant therapy
* Willing and able to withdraw specific therapies (ask PI)
* Medically acceptable form of contraception (female only)
* Signed informed consent
Exclusion Criteria
* Regional or persistent pain that could interfere with assessment of fibromyalgia pain
* Bipolar and psychotic disorders
* Increased risk of suicide
* Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
* Inability to wash-out specific medications (ask PI)
* Known hypersensitivity to cyclobenzaprine
* Others: seizure disorders, severe/untreated sleep apnea, BMI\>40
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
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
Columbus, 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-F301
Identifier Type: -
Identifier Source: org_study_id
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