- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02436096
A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia (AFFIRM)
A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia
The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35216
-
-
Arizona
-
Phoenix, Arizona, United States, 85032
-
-
California
-
Sacramento, California, United States, 95825
-
San Diego, California, United States, 92103
-
-
Florida
-
Brandon, Florida, United States, 33511
-
DeLand, Florida, United States, 32720
-
Lakeland, Florida, United States, 33805
-
Ocala, Florida, United States, 34471
-
Orlando, Florida, United States, 32806
-
Tampa, Florida, United States, 33613
-
Tampa, Florida, United States, 33614
-
West Palm Beach, Florida, United States, 33409
-
-
Georgia
-
Columbus, Georgia, United States, 31904
-
Smyrna, Georgia, United States, 30080
-
-
Indiana
-
Evansville, Indiana, United States, 47714
-
-
Massachusetts
-
North Dartmouth, Massachusetts, United States, 02747
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48104
-
-
Mississippi
-
Jackson, Mississippi, United States, 39202
-
-
New York
-
Williamsville, New York, United States, 14221
-
-
Ohio
-
Cincinnati, Ohio, United States, 45206
-
Columbus, Ohio, United States, 43212
-
Middleburg Heights, Ohio, United States, 44130
-
-
Oregon
-
Medford, Oregon, United States, 97504
-
Portland, Oregon, United States, 97210
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18104
-
-
Rhode Island
-
Warwick, Rhode Island, United States, 02888
-
-
South Carolina
-
Greer, South Carolina, United States, 29650
-
Mount Pleasant, South Carolina, United States, 29464
-
-
Texas
-
Dallas, Texas, United States, 75231
-
-
Utah
-
Salt Lake City, Utah, United States, 84102
-
-
Virginia
-
Charlottesville, Virginia, United States, 22911
-
Norfolk, Virginia, United States, 23507
-
-
Washington
-
Bellevue, Washington, United States, 98007
-
Seattle, Washington, United States, 98104
-
-
Wisconsin
-
Kenosha, Wisconsin, United States, 53142
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
- Male or female 18-75 years old
- For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant therapy
- Willing and able to withdraw specific therapies (ask PI)
- Medically acceptable form of contraception (female only)
- Signed informed consent
Exclusion Criteria:
- Arthritis, lupus and other systemic auto-immune diseases
- Regional or persistent pain that could interfere with assessment of fibromyalgia pain
- Bipolar and psychotic disorders
- Increased risk of suicide
- Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
- Unability to wash-out specific medications (ask PI)
- Known hypersensitivity to cyclobenzaprine
- Others: seizure disorders, severe/untreated sleep apnea, BMI>40
Study Plan
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 |
---|---|
Experimental: TNX-102 SL Tablet, 2.8 mg
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
|
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Other Names:
|
Placebo Comparator: Placebo SL Tablet
1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks
|
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average perceived pain
Time Frame: Week 12
|
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain severity score using an 11-point (0-10) NRS.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's Global Impression of Change (PGIC)
Time Frame: Week 12
|
Proportion of patients with a PGIC of "very much improved" or "much improved" rating at Week 12
|
Week 12
|
Fibromyalgia Impact Questionnaire (FIQR)
Time Frame: Week 12
|
Change from Baseline in the FIQR total score at Week12
|
Week 12
|
Patient Reported Outcomes Measurement System (PROMIS)
Time Frame: Week 12
|
Change from baseline in the PROMIS score for sleep disturbance at Week 12
|
Week 12
|
Daily Diary sleep
Time Frame: Week 12
|
Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12
|
Week 12
|
Patient Reported Outcomes Measurement System (PROMIS)
Time Frame: Week 12
|
Change from Baseline in the PROMIS score for fatigue at Week 12
|
Week 12
|
Daily Diary pain
Time Frame: Week 12
|
Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score
|
Week 12
|
Safety of TNX-102 SL Tablets
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
|
Incidence of adverse events
|
Continuously throughout the treatment period (total duration: about 3 months)
|
Safety of TNX-102 SL Tablets assessed by changes from baseline in clinical laboratory tests
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
|
Continuously throughout the treatment period (total duration: about 3 months)
|
|
Safety of TNX-102 SL Tablets assessed by changes from baseline in vital signs
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
|
Continuously throughout the treatment period (total duration: about 3 months)
|
|
Safety of TNX-102 SL Tablets assessed by changes from baseline in physical examination findings including examination of the oral cavity
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
|
Continuously throughout the treatment period (total duration: about 3 months)
|
|
Safety of TNX-102 SL Tablets assessed by Monitoring suicidality using the C-SSRS scale
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
|
Continuously throughout the treatment period (total duration: about 3 months)
|
|
Safety of TNX-102 Sub lingual (SL) Tablets assessed by changes from baseline in BDI scores.
Time Frame: Continuously throughout the treatment period (total duration: about 3 months)
|
Continuously throughout the treatment period (total duration: about 3 months)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Connective Tissue Diseases
- Fibromyalgia
- Nervous System Diseases
- Myofascial Pain Syndromes
- Rheumatic Diseases
- Collagen Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- 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-F301
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.
Clinical Trials on Nervous System Diseases
-
Bracco Diagnostics, IncCompletedCentral Nervous System Neoplasms | Central Nervous System Disease
-
Bracco Diagnostics, IncCompletedCentral Nervous System Diseases | Central Nervous System NeoplasmsUnited States
-
Bracco Diagnostics, IncCompletedCentral Nervous System Diseases | Central Nervous System NeoplasmsUnited States
-
UNC Lineberger Comprehensive Cancer CenterRecruitingCentral Nervous System TumorUnited States
-
University of MichiganCompletedAutonomic Peripheral Nervous System DiseasesUnited States
-
Washington University School of MedicineRecruitingCentral Nervous SystemUnited States
-
Weill Medical College of Cornell UniversityRecruitingCentral Nervous System Tumor | Pediatric Central Nervous System TumorUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
National Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)TerminatedBrain and Central Nervous System TumorsUnited States
Clinical Trials on TNX-102 SL Tablet, 2.8mg
-
Tonix Pharmaceuticals, Inc.CompletedCOVID-19 | Long COVID | Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection | Long Haul COVIDUnited States
-
Tonix Pharmaceuticals, Inc.Completed
-
Tonix Pharmaceuticals, Inc.Completed
-
Tonix Pharmaceuticals, Inc.Completed
-
Tonix Pharmaceuticals, Inc.Completed
-
Tonix Pharmaceuticals, Inc.Completed
-
Tonix Pharmaceuticals, Inc.Terminated
-
Tonix Pharmaceuticals, Inc.CompletedPrimary FibromyalgiaUnited States
-
Tonix Pharmaceuticals, Inc.TerminatedNervous System Diseases | Musculoskeletal Diseases | Rheumatic Diseases | Muscular Diseases | Neuromuscular Diseases | Fibromyalgia | Myofascial Pain SyndromesUnited States
-
Tonix Pharmaceuticals, Inc.CompletedFibromyalgiaUnited States