Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia
NCT ID: NCT02829814
Last Updated: 2025-02-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
51 participants
INTERVENTIONAL
2016-07-22
2016-09-13
Brief Summary
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The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.
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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 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8 mg
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 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 0 for 12 weeks.
Interventions
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TNX-102 SL Tablet, 2.8 mg
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Placebo SL Tablet
Patients will take 1 tablet 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
* Male or female 18-75 years old
* Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame.
* Willing and able to withdraw specific therapies (ask PI)
* If female, medically acceptable form of contraception or not of child bearing potential.
* Provide written informed consent to participate.
* Willing and able to comply with all protocol specified requirement.
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\>45
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
Oceanside, California, United States
San Diego, California, United States
Brandon, Florida, United States
DeLand, 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
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Jackson, Mississippi, United States
Las Vegas, Nevada, United States
Cedarhurst, New York, United States
Williamsville, New York, United States
Raleigh, North Carolina, United States
Fargo, North Dakota, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Medford, Oregon, United States
Portland, Oregon, United States
Salem, Oregon, United States
Allentown, Pennsylvania, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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TNX-CY-F302
Identifier Type: -
Identifier Source: org_study_id
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