Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1 (FORTRESS)

September 25, 2022 updated by: Virios Therapeutics, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

422

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • IMC Study Site
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • IMC Study Site
    • California
      • Oceanside, California, United States, 92056
        • IMC Study Site
      • Riverside, California, United States, 92503
        • IMC Study Site
      • Sacramento, California, United States, 95831
        • IMC Study Site
      • San Diego, California, United States, 92103
        • IMC Study Site
      • Santa Ana, California, United States, 92705
        • IMC Study Site
      • Temecula, California, United States, 92591
        • IMC Study Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • IMC Study Site
      • Ocala, Florida, United States, 34470
        • IMC Study Site
      • Oldsmar, Florida, United States, 34677
        • IMC Study Site
      • Orlando, Florida, United States, 32801
        • IMC Study Site
      • Tampa, Florida, United States, 33614
        • IMC Study Site
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • IMC Study Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • IMC Study Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • IMC Study Site
    • Iowa
      • Des Moines, Iowa, United States, 50265
        • IMC Study Site
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • IMC Study Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • IMC Study Site
      • New Orleans, Louisiana, United States, 70124
        • IMC Study Site
      • Prairieville, Louisiana, United States, 70769
        • IMC Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • IMC Study Site
      • North Dartmouth, Massachusetts, United States, 02747
        • IMC Study Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • IMC Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • IMC Study Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • IMC Study Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • IMC Study Site
      • Williamsville, New York, United States, 14221
        • IMC Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • IMC Study Site
      • North Canton, Ohio, United States, 44720
        • IMC Study Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • IMC Study Site
      • Tulsa, Oklahoma, United States, 74133
        • IMC Study Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • IMC Study Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • IMC Study Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • IMC Study Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • IMC Study Site
      • Knoxville, Tennessee, United States, 37912
        • IMC Study Site
    • Texas
      • Austin, Texas, United States, 78737
        • IMC Study Site
      • Dallas, Texas, United States, 75231
        • IMC Study Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • IMC Study Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • IMC Study Site
    • Washington
      • Everett, Washington, United States, 98201
        • IMC Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMC-1 Oral Tablet
2X IMC-1 Tablet taken orally, each morning and evening.
Drug: IMC-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.
Placebo Comparator: Placebo
2X Placebo Tablet taken orally, each morning and evening.
Drug: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virios Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2021

Primary Completion (Actual)

August 5, 2022

Study Completion (Actual)

August 5, 2022

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRID-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No: There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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