Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1
- Registration Number
- NCT04748705
- Lead Sponsor
- Virios Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 422
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMC-1 Oral Tablet IMC-1 2X IMC-1 Tablet taken orally, each morning and evening. Placebo Placebo BID Tablet 2X Placebo Tablet taken orally, each morning and evening.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
IMC Study Site
🇺🇸Everett, Washington, United States
IMC Study SIte
🇺🇸Prairie Village, Kansas, United States