- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04172831
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia (RELIEF)
July 13, 2022 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)
503
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 Locations
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Alabama
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Birmingham, Alabama, United States, 35216
- Tonix Clinical Site
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Arizona
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Phoenix, Arizona, United States, 85016
- Tonix Clinical Site
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California
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Oceanside, California, United States, 92056
- Tonix Clinical Site
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Sacramento, California, United States, 95831
- Tonix Clinical Site
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San Diego, California, United States, 92103
- Tonix Clinical Site
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Temecula, California, United States, 32591
- 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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North Miami, Florida, United States, 33161
- Tonix Clinical Site
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Ocala, Florida, United States, 34470
- Tonix Clinical Site
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Orlando, Florida, United States, 32801
- Tonix Clinical Site
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Georgia
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Atlanta, Georgia, United States, 30341
- 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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New Orleans, Louisiana, United States, 70115
- Tonix Clinical Site
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Massachusetts
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Boston, Massachusetts, United States, 02131
- Tonix Clinical Site
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North Dartmouth, Massachusetts, United States, 02747
- Tonix Clinical Site
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Nevada
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Las Vegas, Nevada, United States, 89102
- 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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North Carolina
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High Point, North Carolina, United States, 27262
- Tonix Clinical Site
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Raleigh, North Carolina, United States, 27612
- Tonix Clinical Site
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North Dakota
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Fargo, North Dakota, United States, 58104
- Tonix Clinical Site
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Ohio
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Cincinnati, Ohio, United States, 45219
- Tonix Clinical Site
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Dayton, Ohio, United States, 45417
- Tonix Clinical Site
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North Canton, Ohio, United States, 44720
- Tonix Clinical Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Tonix Clinical Site
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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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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Tonix Clinical Site
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Rhode Island
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Warwick, Rhode Island, United States, 02886
- Tonix Clinical Site
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Tennessee
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Chattanooga, Tennessee, United States, 37421
- Tonix Clinical Site
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Memphis, Tennessee, United States, 38119
- 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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Utah
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Salt Lake City, Utah, United States, 84102
- Tonix Clinical Site
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Virginia
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Charlottesville, Virginia, United States, 22911
- 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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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)
- The in-clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol specified range.
Exclusion Criteria:
- History of or evidence for a diagnosis of borderline personality disorder (BPD).
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 |
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Experimental: TNX-102 SL Tablets, 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.
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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.
Other Names:
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.
Time Frame: 14 weeks
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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).
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14 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved"
Time Frame: 14 weeks
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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.
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14 weeks
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Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score
Time Frame: 14 weeks
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The FIQ-R is a validated questionnaire.
Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome.
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14 weeks
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Change From Baseline to Week 14 in the FIQR Function Domain Score
Time Frame: 14 weeks
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The FIQ-R is a validated questionnaire.
Scores on the function domain range from 0 to 90 where a higher score means worse outcome.
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14 weeks
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Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance
Time Frame: 14 weeks
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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.
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14 weeks
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Change From Baseline to Week 14 in the PROMIS Score for Fatigue
Time Frame: 14 weeks
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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.
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14 weeks
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Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality
Time Frame: 14 weeks
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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).
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14 weeks
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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
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)
December 9, 2019
Primary Completion (Actual)
October 29, 2020
Study Completion (Actual)
October 29, 2020
Study Registration Dates
First Submitted
November 20, 2019
First Submitted That Met QC Criteria
November 20, 2019
First Posted (Actual)
November 21, 2019
Study Record Updates
Last Update Posted (Actual)
August 8, 2022
Last Update Submitted That Met QC Criteria
July 13, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Neuromuscular Agents
- Muscle Relaxants, Central
- Cyclobenzaprine
Other Study ID Numbers
- TNX-CY-F304
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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