Status:
COMPLETED
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 bed...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- The patient has been diagnosed with infectious or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attacks within past 2 years is exclusionary), or meets criteria for other type of systemic autoimmune disease.
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2023
Estimated Enrollment :
457 Patients enrolled
Trial Details
Trial ID
NCT05273749
Start Date
April 6 2022
End Date
November 14 2023
Last Update
January 22 2025
Active Locations (33)
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1
Tonix Clinical Site
Phoenix, Arizona, United States, 85012
2
Tonix Clinical Site
Oceanside, California, United States, 92056
3
Tonix Clinical Site
Santa Ana, California, United States, 92705
4
Tonix Clinical Site
Temecula, California, United States, 92591