A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
RELIEF
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
503
1 country
39
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 Dec 2019
Shorter than P25 for phase_3
39 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
November 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 21, 2019
CompletedStudy Start
First participant enrolled
December 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2020
CompletedResults Posted
Study results publicly available
August 8, 2022
CompletedAugust 8, 2022
July 1, 2022
11 months
November 20, 2019
June 2, 2022
July 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.
Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
14 weeks
Secondary Outcomes (6)
Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved"
14 weeks
Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score
14 weeks
Change From Baseline to Week 14 in the FIQR Function Domain Score
14 weeks
Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance
14 weeks
Change From Baseline to Week 14 in the PROMIS Score for Fatigue
14 weeks
- +1 more secondary outcomes
Study Arms (2)
TNX-102 SL Tablets, 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)
- The in-clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol specified range.
You may not qualify if:
- History of or evidence for a diagnosis of borderline personality disorder (BPD).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Tonix Clinical Site
Birmingham, Alabama, 35216, United States
Tonix Clinical Site
Phoenix, Arizona, 85016, United States
Tonix Clinical Site
Oceanside, California, 92056, United States
Tonix Clinical Site
Sacramento, California, 95831, United States
Tonix Clinical Site
San Diego, California, 92103, United States
Tonix Clinical Site
Temecula, California, 32591, 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
North Miami, Florida, 33161, United States
Tonix Clinical Site
Ocala, Florida, 34470, United States
Tonix Clinical Site
Orlando, Florida, 32801, United States
Tonix Clinical Site
Atlanta, Georgia, 30341, 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
New Orleans, Louisiana, 70115, United States
Tonix Clinical Site
Boston, Massachusetts, 02131, United States
Tonix Clinical Site
North Dartmouth, Massachusetts, 02747, United States
Tonix Clinical Site
Las Vegas, Nevada, 89102, United States
Tonix Clinical Site
Williamsville, New York, 14221, United States
Tonix Clinical Site
High Point, North Carolina, 27262, United States
Tonix Clinical Site
Raleigh, North Carolina, 27612, United States
Tonix Clinical Site
Fargo, North Dakota, 58104, United States
Tonix Clinical Site
Cincinnati, Ohio, 45219, United States
Tonix Clinical Site
Dayton, Ohio, 45417, United States
Tonix Clinical Site
North Canton, Ohio, 44720, United States
Tonix Clinical Site
Oklahoma City, Oklahoma, 73112, United States
Tonix Clinical Site
Tulsa, Oklahoma, 74133, United States
Tonix Clinical Site
Portland, Oregon, 97210, United States
Tonix Clinical Site
Allentown, Pennsylvania, 18104, United States
Tonix Clinical Site
Warwick, Rhode Island, 02886, United States
Tonix Clinical Site
Chattanooga, Tennessee, 37421, United States
Tonix Clinical Site
Memphis, Tennessee, 38119, United States
Tonix Clinical Site
Austin, Texas, 78737, United States
Tonix Clinical Site
Dallas, Texas, 75231, United States
Tonix Clinical Site
Salt Lake City, Utah, 84102, United States
Tonix Clinical Site
Charlottesville, Virginia, 22911, United States
Tonix Clinical Site
Kenosha, Wisconsin, 53144, United States
Related Publications (1)
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.
PMID: 37165930DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Recruitment during COVID-19 pandemic
Results Point of Contact
- Title
- Gregory Sullivan, MD
- Organization
- Tonix Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Gregory Sullivan, MD
Tonix Pharmaceuticals
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
November 20, 2019
First Posted
November 21, 2019
Study Start
December 9, 2019
Primary Completion
October 29, 2020
Study Completion
October 29, 2020
Last Updated
August 8, 2022
Results First Posted
August 8, 2022
Record last verified: 2022-07