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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IMC-1
Placebo BID Tablet
Sponsored by
Virios Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • IMC Study Site
  • IMC Study Site
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  • IMC Study SIte
  • IMC Study Site
  • IMC Study Site
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  • IMC Study Site
  • IMC Study Site
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  • IMC Study Site
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  • IMC Study Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMC-1 Oral Tablet

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Pain Score
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

Full Information

First Posted
February 5, 2021
Last Updated
September 25, 2022
Sponsor
Virios Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04748705
Brief Title
Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1
Acronym
FORTRESS
Official Title
A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virios Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMC-1 Oral Tablet
Arm Type
Experimental
Arm Description
2X IMC-1 Tablet taken orally, each morning and evening.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2X Placebo Tablet taken orally, each morning and evening.
Intervention Type
Drug
Intervention Name(s)
IMC-1
Intervention Description
Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
Intervention Type
Drug
Intervention Name(s)
Placebo BID Tablet
Intervention Description
Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
Primary Outcome Measure Information:
Title
Mean Pain Score
Description
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.
Time Frame
16 Week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
IMC Study Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
IMC Study Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
IMC Study Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
IMC Study Site
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
IMC Study Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
IMC Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
IMC Study Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
IMC Study Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
IMC Study Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
IMC Study Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
IMC Study Site
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
IMC Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
IMC Study Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
IMC Study Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
IMC Study Site
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
IMC Study Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
IMC Study Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
IMC Study SIte
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
IMC Study Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
IMC Study Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
IMC Study Site
City
Prairieville
State/Province
Louisiana
ZIP/Postal Code
70769
Country
United States
Facility Name
IMC Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
IMC Study Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
IMC Study Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
IMC Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
IMC Study Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
IMC Study Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
IMC Study Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
IMC Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
IMC Study Site
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
IMC Study Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
IMC Study Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
IMC Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
IMC Study Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
IMC Study Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
IMC Study Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
IMC Study Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
IMC Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
IMC Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
IMC Study Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
IMC Study Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
IMC Study Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No: There is not a plan to make IPD available.
Citations:
PubMed Identifier
28260944
Citation
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.
Results Reference
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Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1

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