Study Stopped
For business reason unrelated to safety or tolerability,Tonix discontinued this study.
Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia
RE-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
51
1 country
32
Brief Summary
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia. The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2016
Shorter than P25 for phase_3
32 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
July 8, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedStudy Start
First participant enrolled
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2016
CompletedResults Posted
Study results publicly available
February 25, 2025
CompletedFebruary 25, 2025
February 1, 2025
2 months
July 8, 2016
February 4, 2025
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weekly Mean Pain Score
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS). A score of 0 indicates "no pain at all", and a score of 10 indicates "worst possible pain".
Day 1, Week 12
Secondary Outcomes (7)
Patient's Global Impression of Change (PGIC)
Week 12
Fibromyalgia Impact Questionnaire (FIQR) Revised, Symptoms Domain
Day 1, Week 12
Fibromyalgia Impact Questionnaire (FIQR) Revised, Functional Domain Score
Day 1, Week 12
Daily Diary Sleep
Week 12
Patient Reported Outcomes Measurement System (PROMIS), Sleep Disturbance
Day 1, Week 12
- +2 more secondary outcomes
Study Arms (2)
TNX-102 SL Tablet, 2.8 mg
EXPERIMENTAL1 x TNX-102 SL 2.8 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 12 weeks
Interventions
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 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.
Eligibility Criteria
You may qualify if:
- Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
- Male or female 18-75 years old
- Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame.
- Willing and able to withdraw specific therapies (ask PI)
- If female, medically acceptable form of contraception or not of child bearing potential.
- Provide written informed consent to participate.
- Willing and able to comply with all protocol specified requirement.
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\>45
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Unknown Facility
Birmingham, Alabama, 35216, United States
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Oceanside, California, 92056, 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
Ocala, Florida, 34471, United States
Unknown Facility
Orlando, Florida, 32801, 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
Evansville, Indiana, 47714, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Jackson, Mississippi, 39202, United States
Unknown Facility
Las Vegas, Nevada, 89102, United States
Unknown Facility
Cedarhurst, New York, 11516, United States
Unknown Facility
Williamsville, New York, 14221, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Fargo, North Dakota, 58103, United States
Unknown Facility
Canton, Ohio, 44718, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Salem, Oregon, 97301, United States
Unknown Facility
Allentown, Pennsylvania, 18104, United States
Unknown Facility
Warwick, Rhode Island, 02888, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Chattanooga, Tennessee, 37421, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Salt Lake City, Utah, 84102, 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
July 8, 2016
First Posted
July 12, 2016
Study Start
July 22, 2016
Primary Completion
September 13, 2016
Study Completion
September 13, 2016
Last Updated
February 25, 2025
Results First Posted
February 25, 2025
Record last verified: 2025-02