A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia

Virios Therapeutics, Inc.2 sites in 1 country422 target enrollmentJune 3, 2021

ConditionsFibromyalgia

InterventionsIMC-1 Placebo BID Tablet

DrugsIMC-1 Placebo BID Tablet

Overview

Phase: Phase 2
Intervention: IMC-1
Conditions: Fibromyalgia
Sponsor: Virios Therapeutics, Inc.
Enrollment: 422
Locations: 2
Primary Endpoint: Mean Pain Score
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 3, 2021

End Date

August 5, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Virios Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

IMC-1 Oral Tablet

2X IMC-1 Tablet taken orally, each morning and evening.

Intervention: IMC-1

Placebo

2X Placebo Tablet taken orally, each morning and evening.

Intervention: Placebo BID Tablet

Outcomes

Primary Outcomes

Mean Pain Score

Time Frame: 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.