This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this suspected virus and thus alleviate fibromyalgia symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
143
IMC Study Site
Birmingham, Alabama, United States
IMC Study Site
Sacramento, California, United States
IMC Study Site
San Diego, California, United States
Change in pain from baseline
Comparison of the change from baseline in patient self reported pain scores between IMC-1 and placebo treatment, over 16 weeks of treatment
Time frame: 16 weeks
Patient Global Impression of Change
Patients will rate their global improvement over the duration of the trial
Time frame: 16 weeks
Fibromyalgia Impact Questionnaire
Time frame: 16 weeks
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IMC Study Site
Vista, California, United States
IMC Study Site
Jacksonville, Florida, United States
IMC Study Site
Tampa, Florida, United States
IMC Study Site
Evansville, Indiana, United States
IMC Study Site
Lafayette, Indiana, United States
IMC Study Site
Ann Arbor, Michigan, United States
IMC Study Site
Raleigh, North Carolina, United States
...and 2 more locations