Status:
COMPLETED
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL 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)
- The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol defined range.
Exclusion
- \- History of or evidence for a diagnosis of borderline personality disorder (BPD).
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT04508621
Start Date
July 22 2020
End Date
November 1 2021
Last Update
December 18 2023
Active Locations (36)
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1
Tonix Clinical Site
Birmingham, Alabama, United States, 35216
2
Tonix Clinical Site
Phoenix, Arizona, United States, 85016
3
Tonix Clinical Site
Oceanside, California, United States, 92056
4
Tonix Clinical Site
San Diego, California, United States, 92103