- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05273749
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia (RESILIENT)
January 18, 2024 updated by: Tonix Pharmaceuticals, Inc.
A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia
This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
457
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mary A Kelley, MPH
- Phone Number: 619-395-5767
- Email: mary.kelley@tonixpharma.com
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85012
- Tonix Clinical Site
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California
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Oceanside, California, United States, 92056
- Tonix Clinical Site
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Santa Ana, California, United States, 92705
- Tonix Clinical Site
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Temecula, California, United States, 92591
- Tonix Clinical Site
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Connecticut
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Cromwell, Connecticut, United States, 06416
- Tonix Clinical Site
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Florida
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Fort Myers, Florida, United States, 33912
- Tonix Clinical Site
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Jacksonville, Florida, United States, 32256
- Tonix Clinical Site
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Miami Lakes, Florida, United States, 33016
- Tonix Clinical Site
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Ocala, Florida, United States, 34470
- Tonix Clinical Site
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Oldsmar, Florida, United States, 34677
- Tonix Clinical Site
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Orlando, Florida, United States, 32801
- Tonix Clinical Site
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Georgia
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Alpharetta, Georgia, United States, 30022
- Tonix Clinical Site
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Atlanta, Georgia, United States, 30329
- Tonix Clinical Site
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Indiana
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Evansville, Indiana, United States, 47714
- Tonix Clinical Site
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Iowa
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West Des Moines, Iowa, United States, 50265
- Tonix Clinical Site
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Kansas
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Prairie Village, Kansas, United States, 66208
- Tonix Clinical Site
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Louisiana
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Covington, Louisiana, United States, 70433
- Tonix Clinical Site
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New Orleans, Louisiana, United States, 70115
- Tonix Clinical Site
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Prairieville, Louisiana, United States, 70769
- Tonix Clinical Site
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Massachusetts
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Boston, Massachusetts, United States, 02131
- Tonix Clinical Site
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Mississippi
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Gulfport, Mississippi, United States, 39501
- Tonix Clinical Site
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Tonix Clinical Site
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New York
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Williamsville, New York, United States, 14221
- Tonix Clinical Site
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Ohio
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Cincinnati, Ohio, United States, 45219
- Tonix Clinical Site
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Oklahoma
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Tulsa, Oklahoma, United States, 74133
- Tonix Clinical Site
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Oregon
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Portland, Oregon, United States, 97210
- Tonix Clinical Site
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South Carolina
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Charleston, South Carolina, United States, 29407
- Tonix Clinical Site
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Texas
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Austin, Texas, United States, 78737
- Tonix Clinical Site
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Dallas, Texas, United States, 75231
- Tonix Clinical Site
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McKinney, Texas, United States, 75070
- Tonix Clinical Site
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Virginia
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Charlottesville, Virginia, United States, 22911
- Tonix Clinical Site
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Danville, Virginia, United States, 24541
- Tonix Clinical Site
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Wisconsin
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Kenosha, Wisconsin, United States, 53144
- Tonix Clinical Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The patient is male or female 18 to 65 years of age, inclusive.
- 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)
Exclusion Criteria:
- The patient has been diagnosed with infectious or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attacks within past 2 years is exclusionary), or meets criteria for other type of systemic autoimmune disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TNX-102 SL Tablet, 2.8 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.
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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.
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Placebo Comparator: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Pain Score
Time Frame: Week 14
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Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores.
Scores range from 0 to 10 where a higher score means worse outcome.
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Week 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
Time Frame: Week 14
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Change from Baseline in the FIQ-R symptoms domain score at the Week 14 endpoint.
Scores on the symptoms domain range from 0 to 90 where a higher score means worse outcome.
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Week 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gregory Sullivan, MD, Tonix Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2022
Primary Completion (Actual)
November 14, 2023
Study Completion (Actual)
November 14, 2023
Study Registration Dates
First Submitted
March 1, 2022
First Submitted That Met QC Criteria
March 1, 2022
First Posted (Actual)
March 10, 2022
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TNX-CY-F307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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