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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04748705

Recruitment Status : Completed

First Posted : February 10, 2021

Last Update Posted : September 27, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Virios Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Drug: IMC-1 Drug: Placebo BID Tablet	Phase 2

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	422 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia
Actual Study Start Date :	June 3, 2021
Actual Primary Completion Date :	August 5, 2022
Actual Study Completion Date :	August 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Fibromyalgia

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748705

Locations

Layout table for location information

United States, Alabama
IMC Study Site
Birmingham, Alabama, United States, 35216
United States, Arkansas
IMC Study Site
Rogers, Arkansas, United States, 72758
United States, California
IMC Study Site
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
United States, Florida
IMC Study Site
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
United States, Georgia
IMC Study Site
Alpharetta, Georgia, United States, 30022
United States, Illinois
IMC Study Site
Gurnee, Illinois, United States, 60031
United States, Indiana
IMC Study Site
Evansville, Indiana, United States, 47714
United States, Iowa
IMC Study Site
Des Moines, Iowa, United States, 50265
United States, Kansas
IMC Study SIte
Prairie Village, Kansas, United States, 66208
United States, Louisiana
IMC Study Site
Covington, Louisiana, United States, 70433
IMC Study Site
New Orleans, Louisiana, United States, 70124
IMC Study Site
Prairieville, Louisiana, United States, 70769
United States, Massachusetts
IMC Study Site
Boston, Massachusetts, United States, 02131
IMC Study Site
North Dartmouth, Massachusetts, United States, 02747
United States, Mississippi
IMC Study Site
Jackson, Mississippi, United States, 39202
United States, Nevada
IMC Study Site
Las Vegas, Nevada, United States, 89102
United States, New Mexico
IMC Study Site
Albuquerque, New Mexico, United States, 87109
United States, New York
IMC Study Site
Cedarhurst, New York, United States, 11516
IMC Study Site
Williamsville, New York, United States, 14221
United States, Ohio
IMC Study Site
Cincinnati, Ohio, United States, 45219
IMC Study Site
North Canton, Ohio, United States, 44720
United States, Oklahoma
IMC Study Site
Oklahoma City, Oklahoma, United States, 73106
IMC Study Site
Tulsa, Oklahoma, United States, 74133
United States, Oregon
IMC Study Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
IMC Study Site
Allentown, Pennsylvania, United States, 18104
United States, Rhode Island
IMC Study Site
Warwick, Rhode Island, United States, 02886
United States, Tennessee
IMC Study Site
Chattanooga, Tennessee, United States, 37421
IMC Study Site
Knoxville, Tennessee, United States, 37912
United States, Texas
IMC Study Site
Austin, Texas, United States, 78737
IMC Study Site
Dallas, Texas, United States, 75231
United States, Utah
IMC Study Site
Salt Lake City, Utah, United States, 84102
United States, Virginia
IMC Study Site
Charlottesville, Virginia, United States, 22911
United States, Washington
IMC Study Site
Everett, Washington, United States, 98201

Sponsors and Collaborators

Virios Therapeutics, Inc.

More Information

Publications:

Pridgen WL, Duffy C, Gendreau JF, Gendreau RM. A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia. J Pain Res. 2017 Feb 22;10:451-460. doi: 10.2147/JPR.S127288. eCollection 2017.

Layout table for additonal information

Responsible Party:	Virios Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT04748705
Other Study ID Numbers:	PRID-202
First Posted:	February 10, 2021 Key Record Dates
Last Update Posted:	September 27, 2022
Last Verified:	September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	No: There is not a plan to make IPD available.

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Virios Therapeutics, Inc.:


Pain

Additional relevant MeSH terms:

Layout table for MeSH terms

Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases	Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases

To Top