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A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia (RESILIENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05273749
Recruitment Status : Recruiting
First Posted : March 10, 2022
Last Update Posted : February 17, 2023
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: TNX-102 SL Drug: Placebo SL Tablet Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 6, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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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.
 Drug: 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 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.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Mean Pain Score [ Time Frame: Week 14 ]
    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.


Secondary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire - Revised (FIQ-R) [ Time Frame: Week 14 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273749


Contacts
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Contact: Mary A Kelley, MPH 619-395-5767 mary.kelley@tonixpharma.com

Locations
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United States, Arizona
Tonix Clinical Site Terminated
Phoenix, Arizona, United States, 85012
United States, California
Tonix Clinical Site Recruiting
Oceanside, California, United States, 92056
Tonix Clinical Site Withdrawn
San Diego, California, United States, 92103
Tonix Clinical Site Recruiting
Santa Ana, California, United States, 92705
Tonix Clinical Site Recruiting
Temecula, California, United States, 92591
United States, Connecticut
Tonix Clinical Site Recruiting
Cromwell, Connecticut, United States, 06416
United States, Florida
Tonix Clinical Site Recruiting
Fort Myers, Florida, United States, 33912
Tonix Clinical Site Recruiting
Jacksonville, Florida, United States, 32256
Tonix Clinical Site Recruiting
Miami Lakes, Florida, United States, 33016
Tonix Clinical Site Recruiting
Ocala, Florida, United States, 34470
Tonix Clinical Site Recruiting
Oldsmar, Florida, United States, 34677
Tonix Clinical Site Recruiting
Orlando, Florida, United States, 32801
Tonix Clinical Site Withdrawn
Sarasota, Florida, United States, 34243
United States, Georgia
Tonix Clinical Site Recruiting
Alpharetta, Georgia, United States, 30022
Tonix Clinical Site Recruiting
Atlanta, Georgia, United States, 30329
United States, Indiana
Tonix Clinical Site Recruiting
Evansville, Indiana, United States, 47714
United States, Iowa
Tonix Clinical Site Recruiting
West Des Moines, Iowa, United States, 50265
United States, Kansas
Tonix Clinical Site Recruiting
Prairie Village, Kansas, United States, 66208
United States, Louisiana
Tonix Clinical Site Recruiting
Covington, Louisiana, United States, 70433
Tonix Clinical Site Recruiting
New Orleans, Louisiana, United States, 70115
Tonix Clinical Site Recruiting
Prairieville, Louisiana, United States, 70769
United States, Massachusetts
Tonix Clinical Site Recruiting
Boston, Massachusetts, United States, 02131
United States, Mississippi
Tonix Clinical Site Recruiting
Gulfport, Mississippi, United States, 39501
United States, New Mexico
Tonix Clinical Site Recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
Tonix Clinical Site Recruiting
Williamsville, New York, United States, 14221
United States, Ohio
Tonix Clinical Site Recruiting
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Tonix Clinical Site Recruiting
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Tonix Clinical Site Recruiting
Portland, Oregon, United States, 97210
United States, South Carolina
Tonix Clinical Site Recruiting
Charleston, South Carolina, United States, 29407
United States, Texas
Tonix Clinical Site Recruiting
Austin, Texas, United States, 78737
Tonix Clinical Site Recruiting
Dallas, Texas, United States, 75231
Tonix Clinical Site Recruiting
McKinney, Texas, United States, 75070
United States, Virginia
Tonix Clinical Site Recruiting
Charlottesville, Virginia, United States, 22911
Tonix Clinical Site Recruiting
Danville, Virginia, United States, 24541
United States, Wisconsin
Tonix Clinical Site Recruiting
Kenosha, Wisconsin, United States, 53144
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
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Study Director: Gregory Sullivan, MD Tonix Pharmaceuticals, Inc.
More Information
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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05273749    
Other Study ID Numbers: TNX-CY-F307
First Posted: March 10, 2022    Key Record Dates
Last Update Posted: February 17, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tonix Pharmaceuticals, Inc.:
Pain, Sleep, Fibromyalgia, FM
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases