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NCT04748705 Clinical Trial

Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1

Fibromyalgia Clinical Trial

— FORTRESS  

Official title:
A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04748705
Other study ID # PRID-202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 3, 2021
Est. completion date August 5, 2022

Study information
Verified date September 2022
Source Virios Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized, double-blind, placebo-controlled, 16-week study designed to explore the safety and efficacy of IMC-1 for the treatment of patients with fibromyalgia.

Recruitment information / eligibility
Status Completed
Enrollment 422
Est. completion date August 5, 2022
Est. primary completion date August 5, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - The patient is 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 VAS scale average daily pain intensity score at Screening visit within protocol defined range. Exclusion Criteria: - Any underlying medical or psychiatric condition that could impact their safe participation per protocol.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IMC-1
Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
• Placebo BID Tablet
Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.

Locations
Country Name City State
United States IMC Study Site Albuquerque New Mexico
United States IMC Study Site Allentown Pennsylvania
United States IMC Study Site Alpharetta Georgia
United States IMC Study Site Austin Texas
United States IMC Study Site Birmingham Alabama
United States IMC Study Site Boston Massachusetts
United States IMC Study Site Cedarhurst New York
United States IMC Study Site Charlottesville Virginia
United States IMC Study Site Chattanooga Tennessee
United States IMC Study Site Cincinnati Ohio
United States IMC Study Site Covington Louisiana
United States IMC Study Site Dallas Texas
United States IMC Study Site Des Moines Iowa
United States IMC Study Site Evansville Indiana
United States IMC Study Site Everett Washington
United States IMC Study Site Gurnee Illinois
United States IMC Study Site Jackson Mississippi
United States IMC Study Site Jacksonville Florida
United States IMC Study Site Knoxville Tennessee
United States IMC Study Site Las Vegas Nevada
United States IMC Study Site New Orleans Louisiana
United States IMC Study Site North Canton Ohio
United States IMC Study Site North Dartmouth Massachusetts
United States IMC Study Site Ocala Florida
United States IMC Study Site Oceanside California
United States IMC Study Site Oklahoma City Oklahoma
United States IMC Study Site Oldsmar Florida
United States IMC Study Site Orlando Florida
United States IMC Study Site Portland Oregon
United States IMC Study SIte Prairie Village Kansas
United States IMC Study Site Prairieville Louisiana
United States IMC Study Site Riverside California
United States IMC Study Site Rogers Arkansas
United States IMC Study Site Sacramento California
United States IMC Study Site Salt Lake City Utah
United States IMC Study Site San Diego California
United States IMC Study Site Santa Ana California
United States IMC Study Site Tampa Florida
United States IMC Study Site Temecula California
United States IMC Study Site Tulsa Oklahoma
United States IMC Study Site Warwick Rhode Island
United States IMC Study Site Williamsville New York

Sponsors (1)
Lead Sponsor Collaborator
Virios Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pridgen WL, Duffy C, Gendreau JF, Gendreau RM. A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia. J Pain Res. 2017 Feb 22;10:451-460. doi: 10.2147/JPR.S127288. eCollection 2017. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Pain Score Change from Baseline to Week 16 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. 16 Week
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