Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1

  • End date
    Jul 1, 2022
  • participants needed
  • sponsor
    Virios Therapeutics, Inc.
Updated on 1 September 2021
sham treatment


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.

Condition Fibromyalgia, Myofascial Pain Syndrome, fibro
Treatment INC-1, Placebo BID Tablet, IMC-1
Clinical Study IdentifierNCT04748705
SponsorVirios Therapeutics, Inc.
Last Modified on1 September 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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