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NCT05273749 Clinical Trial

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

— RESILIENT  

Official title:
A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05273749
Other study ID # TNX-CY-F307
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 6, 2022
Est. completion date November 14, 2023

Study information
Verified date January 2024
Source Tonix Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 bedtime for the treatment of fibromyalgia.

Recruitment information / eligibility
Status Completed
Enrollment 457
Est. completion date November 14, 2023
Est. primary completion date November 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TNX-102 SL
Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
• Placebo SL Tablet
Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.

Locations
Country Name City State
United States Tonix Clinical Site Albuquerque New Mexico
United States Tonix Clinical Site Alpharetta Georgia
United States Tonix Clinical Site Atlanta Georgia
United States Tonix Clinical Site Austin Texas
United States Tonix Clinical Site Boston Massachusetts
United States Tonix Clinical Site Charleston South Carolina
United States Tonix Clinical Site Charlottesville Virginia
United States Tonix Clinical Site Cincinnati Ohio
United States Tonix Clinical Site Covington Louisiana
United States Tonix Clinical Site Cromwell Connecticut
United States Tonix Clinical Site Dallas Texas
United States Tonix Clinical Site Danville Virginia
United States Tonix Clinical Site Evansville Indiana
United States Tonix Clinical Site Fort Myers Florida
United States Tonix Clinical Site Gulfport Mississippi
United States Tonix Clinical Site Jacksonville Florida
United States Tonix Clinical Site Kenosha Wisconsin
United States Tonix Clinical Site McKinney Texas
United States Tonix Clinical Site Miami Lakes Florida
United States Tonix Clinical Site New Orleans Louisiana
United States Tonix Clinical Site Ocala Florida
United States Tonix Clinical Site Oceanside California
United States Tonix Clinical Site Oldsmar Florida
United States Tonix Clinical Site Orlando Florida
United States Tonix Clinical Site Phoenix Arizona
United States Tonix Clinical Site Portland Oregon
United States Tonix Clinical Site Prairie Village Kansas
United States Tonix Clinical Site Prairieville Louisiana
United States Tonix Clinical Site Santa Ana California
United States Tonix Clinical Site Temecula California
United States Tonix Clinical Site Tulsa Oklahoma
United States Tonix Clinical Site West Des Moines Iowa
United States Tonix Clinical Site Williamsville New York

Sponsors (1)
Lead Sponsor Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Pain Score Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome. Week 14
Secondary Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Change from Baseline in the FIQ-R symptoms domain score at the Week 14 endpoint. Scores on the symptoms domain range from 0 to 90 where a higher score means worse outcome. Week 14
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