Fibromyalgia
Conditions
Keywords
Pain
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.
Interventions
DRUGIMC-1
Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
DRUGPlacebo BID Tablet
Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
Sponsors
Virios Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Score | 16 Week | Change from Baseline to Week 16 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome. |
Countries
United States
Outcome results
None listed