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

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: Fibromyalgia
• Intervention / Treatment: Drug: Placebo SL Tablet; Drug: TNX-102 SL Tablet, 5.6 mg

• Study Type: Interventional
• Enrollment (Actual): 457
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Tonix Clinical Site
  • California
    • Oceanside, California, United States, 92056
      • Tonix Clinical Site
    • Santa Ana, California, United States, 92705
      • Tonix Clinical Site
    • Temecula, California, United States, 92591
      • Tonix Clinical Site
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Tonix Clinical Site
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Tonix Clinical Site
    • Jacksonville, Florida, United States, 32256
      • Tonix Clinical Site
    • Miami Lakes, Florida, United States, 33016
      • Tonix Clinical Site
    • Ocala, Florida, United States, 34470
      • Tonix Clinical Site
    • Oldsmar, Florida, United States, 34677
      • Tonix Clinical Site
    • Orlando, Florida, United States, 32801
      • Tonix Clinical Site
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Tonix Clinical Site
    • Atlanta, Georgia, United States, 30329
      • Tonix Clinical Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Tonix Clinical Site
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Tonix Clinical Site
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • Tonix Clinical Site
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Tonix Clinical Site
    • New Orleans, Louisiana, United States, 70115
      • Tonix Clinical Site
    • Prairieville, Louisiana, United States, 70769
      • Tonix Clinical Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Tonix Clinical Site
  • Mississippi
    • Gulfport, Mississippi, United States, 39501
      • Tonix Clinical Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Tonix Clinical Site
  • New York
    • Williamsville, New York, United States, 14221
      • Tonix Clinical Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Tonix Clinical Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Tonix Clinical Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Tonix Clinical Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Tonix Clinical Site
  • Texas
    • Austin, Texas, United States, 78737
      • Tonix Clinical Site
    • Dallas, Texas, United States, 75231
      • Tonix Clinical Site
    • McKinney, Texas, United States, 75070
      • Tonix Clinical Site
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Tonix Clinical Site
    • Danville, Virginia, United States, 24541
      • Tonix Clinical Site
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Tonix Clinical Site

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: Placebo sublingual tablets
Experimental: TNX-102 SL Tablet, 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.	Drug: TNX-102 SL Tablet, 5.6 mg; 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 Names: Low dose cyclobenzaprine sublingual tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to the Week 14 Endpoint in the Diary NRS Weekly Average of Daily Self Reported Average Pain Severity Scores.	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.	Baseline (Day -7 to Day -1), Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" at the Week 14 Endpoint	The PGIC is a fibromyalgia specific validated instrument on a scale of 1 to 7, where a score of 1 indicates the highest level of improvement and a score of 7 indicates a much worse outcome.	Week 14
Change From Baseline in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score at the Week 14 Endpoint	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.	Day 1, Week 14
Change From Baseline in the FIQ-R Function Domain Score at the Week 14 Endpoint	The FIQ-R is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.	Day 1, Week 14
Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance at the Week 14 Endpoint	The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.	Day 1, Week 14
Change From Baseline in the PROMIS Score for Fatigue at the Week 14 Endpoint	The PROMIS fatigue short form 8a consists of 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.	Day 1, Week 14
Change From Baseline in the Weekly Average of the Daily Diary Assessment of Sleep Quality at the Week 14 Endpoint	Patients provide a daily numeric assessment of their sleep quality for the previous night, via an electronic diary, using an 11-point NRS. Scores range from 0 (best possible sleep) to 10 (worst possible sleep).	Baseline (Day -7 to Day -1), Week 14

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.
• Investigators: Study Director: Gregory Sullivan, MD, Tonix Pharmaceuticals, Inc.

Study record dates

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Pain, Sleep, Fibromyalgia, FM
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Neuromuscular Agents; Muscle Relaxants, Central; Antidepressive Agents, Tricyclic; Cyclobenzaprine
• 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