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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
422
Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
Mean Pain Score
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.
Time frame: 16 Week
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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
...and 32 more locations