Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1
NCT ID: NCT04748705
Last Updated: 2022-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
422 participants
INTERVENTIONAL
2021-06-03
2022-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IMC-1 Oral Tablet
2X IMC-1 Tablet taken orally, each morning and evening.
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
2X Placebo Tablet taken orally, each morning and evening.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Virios Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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IMC Study Site
Birmingham, Alabama, United States
IMC Study Site
Rogers, Arkansas, United States
IMC Study Site
Oceanside, California, United States
IMC Study Site
Riverside, California, United States
IMC Study Site
Sacramento, California, United States
IMC Study Site
San Diego, California, United States
IMC Study Site
Santa Ana, California, United States
IMC Study Site
Temecula, California, United States
IMC Study Site
Jacksonville, Florida, United States
IMC Study Site
Ocala, Florida, United States
IMC Study Site
Oldsmar, Florida, United States
IMC Study Site
Orlando, Florida, United States
IMC Study Site
Tampa, Florida, United States
IMC Study Site
Alpharetta, Georgia, United States
IMC Study Site
Gurnee, Illinois, United States
IMC Study Site
Evansville, Indiana, United States
IMC Study Site
Des Moines, Iowa, United States
IMC Study SIte
Prairie Village, Kansas, United States
IMC Study Site
Covington, Louisiana, United States
IMC Study Site
New Orleans, Louisiana, United States
IMC Study Site
Prairieville, Louisiana, United States
IMC Study Site
Boston, Massachusetts, United States
IMC Study Site
North Dartmouth, Massachusetts, United States
IMC Study Site
Jackson, Mississippi, United States
IMC Study Site
Las Vegas, Nevada, United States
IMC Study Site
Albuquerque, New Mexico, United States
IMC Study Site
Cedarhurst, New York, United States
IMC Study Site
Williamsville, New York, United States
IMC Study Site
Cincinnati, Ohio, United States
IMC Study Site
North Canton, Ohio, United States
IMC Study Site
Oklahoma City, Oklahoma, United States
IMC Study Site
Tulsa, Oklahoma, United States
IMC Study Site
Portland, Oregon, United States
IMC Study Site
Allentown, Pennsylvania, United States
IMC Study Site
Warwick, Rhode Island, United States
IMC Study Site
Chattanooga, Tennessee, United States
IMC Study Site
Knoxville, Tennessee, United States
IMC Study Site
Austin, Texas, United States
IMC Study Site
Dallas, Texas, United States
IMC Study Site
Salt Lake City, Utah, United States
IMC Study Site
Charlottesville, Virginia, United States
IMC Study Site
Everett, Washington, United States
Countries
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References
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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.
Other Identifiers
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PRID-202
Identifier Type: -
Identifier Source: org_study_id
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