Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1

Completed · Phase 2 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT04748705

Run by

Virios Therapeutics, Inc.

People needed

422

Starts

2021-06-03

Expected to finish

2022-08-05

Last updated by the study team

2022-09-27

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Any underlying medical or psychiatric condition that could impact their safe participation per protocol.

Where it is running

• 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

Full record on ClinicalTrials.gov

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