Clinical trial NCT04748705: Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1
Official title: A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Pain
Lead sponsor: Virios Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 422
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Pain Score
timeFrame: 16 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: IMC Study Site
state: Alabama
city: Rogers
country: United States
facility: IMC Study Site
state: Arkansas
city: Oceanside
country: United States
facility: IMC Study Site
state: California
city: Riverside
country: United States
facility: IMC Study Site
state: California
city: Sacramento
country: United States
facility: IMC Study Site
state: California
city: San Diego
country: United States
facility: IMC Study Site
state: California
city: Santa Ana
country: United States
facility: IMC Study Site
state: California
city: Temecula
country: United States
facility: IMC Study Site
state: California
city: Jacksonville
country: United States
facility: IMC Study Site
state: Florida
city: Ocala
country: United States
facility: IMC Study Site
state: Florida
city: Oldsmar
country: United States
facility: IMC Study Site
state: Florida
city: Orlando
country: United States
facility: IMC Study Site
state: Florida
city: Tampa
country: United States
facility: IMC Study Site
state: Florida
city: Alpharetta
country: United States
facility: IMC Study Site
state: Georgia
city: Gurnee
country: United States
facility: IMC Study Site
state: Illinois
city: Evansville
country: United States
facility: IMC Study Site
state: Indiana
city: Des Moines
country: United States
facility: IMC Study Site
state: Iowa
city: Prairie Village
country: United States
facility: IMC Study SIte
state: Kansas
city: Covington
country: United States
facility: IMC Study Site
state: Louisiana
city: New Orleans
country: United States
facility: IMC Study Site
state: Louisiana
city: Prairieville
country: United States
facility: IMC Study Site
state: Louisiana
city: Boston
country: United States
facility: IMC Study Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: IMC Study Site
state: Massachusetts
city: Jackson
country: United States
facility: IMC Study Site
state: Mississippi
city: Las Vegas
country: United States
facility: IMC Study Site
state: Nevada
city: Albuquerque
country: United States
facility: IMC Study Site
state: New Mexico
city: Cedarhurst
country: United States
facility: IMC Study Site
state: New York
city: Williamsville
country: United States
facility: IMC Study Site
state: New York
city: Cincinnati
country: United States
facility: IMC Study Site
state: Ohio
city: North Canton
country: United States
facility: IMC Study Site
state: Ohio
city: Oklahoma City
country: United States
facility: IMC Study Site
state: Oklahoma
city: Tulsa
country: United States
facility: IMC Study Site
state: Oklahoma
city: Portland
country: United States
facility: IMC Study Site
state: Oregon
city: Allentown
country: United States
facility: IMC Study Site
state: Pennsylvania
city: Warwick
country: United States
facility: IMC Study Site
state: Rhode Island
city: Chattanooga
country: United States
facility: IMC Study Site
state: Tennessee
city: Knoxville
country: United States
facility: IMC Study Site
state: Tennessee
city: Austin
country: United States
facility: IMC Study Site
state: Texas
city: Dallas
country: United States
facility: IMC Study Site
state: Texas
city: Salt Lake City
country: United States
facility: IMC Study Site
state: Utah
city: Charlottesville
country: United States
facility: IMC Study Site
state: Virginia
city: Everett
country: United States
facility: IMC Study Site
state: Washington
Study officials:
References:
citation: 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.