A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
NCT ID: NCT04172831
Last Updated: 2022-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
503 participants
INTERVENTIONAL
2019-12-09
2020-10-29
Brief Summary
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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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Placebo SL Tablet
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks then 2 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 starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
TNX-102 SL Tablets, 5.6 mg
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL
Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Interventions
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TNX-102 SL
Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Placebo SL Tablet
Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
* The in-clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol specified range.
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Tonix Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Sullivan, MD
Role: STUDY_DIRECTOR
Tonix Pharmaceuticals
Locations
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Tonix Clinical Site
Birmingham, Alabama, United States
Tonix Clinical Site
Phoenix, Arizona, United States
Tonix Clinical Site
Oceanside, California, United States
Tonix Clinical Site
Sacramento, California, United States
Tonix Clinical Site
San Diego, California, United States
Tonix Clinical Site
Temecula, California, United States
Tonix Clinical Site
Cromwell, Connecticut, United States
Tonix Clinical Site
Fort Myers, Florida, United States
Tonix Clinical Site
Jacksonville, Florida, United States
Tonix Clinical Site
North Miami, Florida, United States
Tonix Clinical Site
Ocala, Florida, United States
Tonix Clinical Site
Orlando, Florida, United States
Tonix Clinical Site
Atlanta, Georgia, United States
Tonix Clinical Site
Evansville, Indiana, United States
Tonix Clinical Site
West Des Moines, Iowa, United States
Tonix Clinical Site
Prairie Village, Kansas, United States
Tonix Clinical Site
New Orleans, Louisiana, United States
Tonix Clinical Site
Boston, Massachusetts, United States
Tonix Clinical Site
North Dartmouth, Massachusetts, United States
Tonix Clinical Site
Las Vegas, Nevada, United States
Tonix Clinical Site
Williamsville, New York, United States
Tonix Clinical Site
High Point, North Carolina, United States
Tonix Clinical Site
Raleigh, North Carolina, United States
Tonix Clinical Site
Fargo, North Dakota, United States
Tonix Clinical Site
Cincinnati, Ohio, United States
Tonix Clinical Site
Dayton, Ohio, United States
Tonix Clinical Site
North Canton, Ohio, United States
Tonix Clinical Site
Oklahoma City, Oklahoma, United States
Tonix Clinical Site
Tulsa, Oklahoma, United States
Tonix Clinical Site
Portland, Oregon, United States
Tonix Clinical Site
Allentown, Pennsylvania, United States
Tonix Clinical Site
Warwick, Rhode Island, United States
Tonix Clinical Site
Chattanooga, Tennessee, United States
Tonix Clinical Site
Memphis, Tennessee, United States
Tonix Clinical Site
Austin, Texas, United States
Tonix Clinical Site
Dallas, Texas, United States
Tonix Clinical Site
Salt Lake City, Utah, United States
Tonix Clinical Site
Charlottesville, Virginia, United States
Tonix Clinical Site
Kenosha, Wisconsin, United States
Countries
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References
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Lederman S, Arnold LM, Vaughn B, Kelley M, Sullivan GM. Efficacy and Safety of Sublingual Cyclobenzaprine for the Treatment of Fibromyalgia: Results From a Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2023 Nov;75(11):2359-2368. doi: 10.1002/acr.25142. Epub 2023 Jul 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TNX-CY-F304
Identifier Type: -
Identifier Source: org_study_id
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