A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
A 3-Month, Multicenter, Open-Label Extension to Evaluate Safety and Efficacy of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia
1 other identifier
interventional
375
1 country
33
Brief Summary
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Patients will not be made aware of the therapy they received during the double-blind study.
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 Aug 2015
Shorter than P25 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2016
CompletedResults Posted
Study results publicly available
December 11, 2024
CompletedFebruary 20, 2025
February 1, 2025
1.2 years
October 19, 2015
November 18, 2024
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Newly Emergent Adverse Events
The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study.
Up to 3 months from first dose
Study Arms (1)
TNX-102 SL Tablet 2.8 mg
EXPERIMENTAL1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months
Interventions
TNX-102 SL 2.8 mg tablet taken daily at bedtime
Eligibility Criteria
You may qualify if:
- The patient completed expected dosing in F301 or F302 defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the F301 or F302 lead-in study) and no major protocol deviations.
- The patient has provided written informed consent to participate in this extension protocol.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
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, 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
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
Interventions
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 28, 2015
Study Start
August 4, 2015
Primary Completion
September 28, 2016
Study Completion
September 28, 2016
Last Updated
February 20, 2025
Results First Posted
December 11, 2024
Record last verified: 2025-02