Overview

Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Virios Therapeutics, Inc.
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.