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
1 other identifier
interventional
519
1 country
35
Brief Summary
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2015
35 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
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
February 7, 2025
CompletedFebruary 7, 2025
February 1, 2025
1.4 years
April 28, 2015
August 21, 2024
February 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients With ≥30% Pain Improvement
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 intensity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Day 1, Week 12
Secondary Outcomes (7)
Patient's Global Impression of Change (PGIC)
Week 12
Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score
Day 1, Week 12
Change From Baseline to Week 12 in the FIQR Function Domain Score
Day 1, Week 12
Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance
Day 1, Week 12
Weekly Average of Daily Sleep Quality Diary
Baseline (Day -7 to Day -1), Week 12
- +2 more secondary outcomes
Study Arms (2)
TNX-102 SL Tablet, 2.8 mg
EXPERIMENTAL1 x TNX-102 SL 2.8mg 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 12 weeks
Interventions
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Inability to wash-out specific medications (ask PI)
- Known hypersensitivity to cyclobenzaprine
- Others: seizure disorders, severe/untreated sleep apnea, BMI\>40
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Unknown Facility
Birmingham, Alabama, 35216, United States
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Sacramento, California, 95825, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Brandon, Florida, 33511, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Lakeland, Florida, 33805, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Tampa, Florida, 33613, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
West Palm Beach, Florida, 33409, United States
Unknown Facility
Columbus, Georgia, 31904, United States
Unknown Facility
Smyrna, Georgia, 30080, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
North Dartmouth, Massachusetts, 02747, United States
Unknown Facility
Ann Arbor, Michigan, 48104, United States
Unknown Facility
Jackson, Mississippi, 39202, United States
Unknown Facility
Williamsville, New York, 14221, United States
Unknown Facility
Cincinnati, Ohio, 45206, United States
Unknown Facility
Columbus, Ohio, 43212, United States
Unknown Facility
Middleburg Heights, Ohio, 44130, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Allentown, Pennsylvania, 18104, United States
Unknown Facility
Warwick, Rhode Island, 02888, United States
Unknown Facility
Greer, South Carolina, 29650, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Salt Lake City, Utah, 84102, United States
Unknown Facility
Charlottesville, Virginia, 22911, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Bellevue, Washington, 98007, United States
Unknown Facility
Seattle, Washington, 98104, United States
Unknown Facility
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gregory Sullivan, MD
- Organization
- 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
April 28, 2015
First Posted
May 6, 2015
Study Start
April 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
February 7, 2025
Results First Posted
February 7, 2025
Record last verified: 2025-02