Status:
COMPLETED
Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1
Lead Sponsor:
Virios Therapeutics, Inc.
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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
- 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
- Any underlying medical or psychiatric condition that could impact their safe participation per protocol.
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2022
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT04748705
Start Date
June 3 2021
End Date
August 5 2022
Last Update
September 27 2022
Active Locations (42)
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1
IMC Study Site
Birmingham, Alabama, United States, 35216
2
IMC Study Site
Rogers, Arkansas, United States, 72758
3
IMC Study Site
Oceanside, California, United States, 92056
4
IMC Study Site
Riverside, California, United States, 92503