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
1 other identifier
interventional
457
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2022
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 10, 2022
CompletedStudy Start
First participant enrolled
April 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2023
CompletedResults Posted
Study results publicly available
December 20, 2024
CompletedJanuary 22, 2025
January 1, 2025
1.6 years
March 1, 2022
November 26, 2024
January 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
Week 14
Change From Baseline in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score at the Week 14 Endpoint
Day 1, Week 14
Change From Baseline in the FIQ-R Function Domain Score at the Week 14 Endpoint
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
Day 1, Week 14
Change From Baseline in the PROMIS Score for Fatigue at the Week 14 Endpoint
Day 1, Week 14
- +1 more secondary outcomes
Study Arms (2)
TNX-102 SL Tablet, 5.6 mg
EXPERIMENTAL1 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.
Placebo SL Tablet
PLACEBO COMPARATOR1 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Tonix Clinical Site
Phoenix, Arizona, 85012, United States
Tonix Clinical Site
Oceanside, California, 92056, United States
Tonix Clinical Site
Santa Ana, California, 92705, United States
Tonix Clinical Site
Temecula, California, 92591, United States
Tonix Clinical Site
Cromwell, Connecticut, 06416, United States
Tonix Clinical Site
Fort Myers, Florida, 33912, United States
Tonix Clinical Site
Jacksonville, Florida, 32256, United States
Tonix Clinical Site
Miami Lakes, Florida, 33016, United States
Tonix Clinical Site
Ocala, Florida, 34470, United States
Tonix Clinical Site
Oldsmar, Florida, 34677, United States
Tonix Clinical Site
Orlando, Florida, 32801, United States
Tonix Clinical Site
Alpharetta, Georgia, 30022, United States
Tonix Clinical Site
Atlanta, Georgia, 30329, United States
Tonix Clinical Site
Evansville, Indiana, 47714, United States
Tonix Clinical Site
West Des Moines, Iowa, 50265, United States
Tonix Clinical Site
Prairie Village, Kansas, 66208, United States
Tonix Clinical Site
Covington, Louisiana, 70433, United States
Tonix Clinical Site
New Orleans, Louisiana, 70115, United States
Tonix Clinical Site
Prairieville, Louisiana, 70769, United States
Tonix Clinical Site
Boston, Massachusetts, 02131, United States
Tonix Clinical Site
Gulfport, Mississippi, 39501, United States
Tonix Clinical Site
Albuquerque, New Mexico, 87109, United States
Tonix Clinical Site
Williamsville, New York, 14221, United States
Tonix Clinical Site
Cincinnati, Ohio, 45219, United States
Tonix Clinical Site
Tulsa, Oklahoma, 74133, United States
Tonix Clinical Site
Portland, Oregon, 97210, United States
Tonix Clinical Site
Charleston, South Carolina, 29407, United States
Tonix Clinical Site
Austin, Texas, 78737, United States
Tonix Clinical Site
Dallas, Texas, 75231, United States
Tonix Clinical Site
McKinney, Texas, 75070, United States
Tonix Clinical Site
Charlottesville, Virginia, 22911, United States
Tonix Clinical Site
Danville, Virginia, 24541, United States
Tonix Clinical Site
Kenosha, Wisconsin, 53144, United States
Related Publications (1)
Lederman S, Arnold LM, Vaughn B, Engels JM, Kelley M, Sullivan GM. Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine. Pain Med. 2026 Jan 1;27(1):86-94. doi: 10.1093/pm/pnaf089.
PMID: 40627411DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gregory Sullivan, MD
- Organization
- Tonix Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Gregory Sullivan, MD
Tonix Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2022
First Posted
March 10, 2022
Study Start
April 6, 2022
Primary Completion
November 14, 2023
Study Completion
November 14, 2023
Last Updated
January 22, 2025
Results First Posted
December 20, 2024
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share