Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1
FORTRESS
A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia
1 other identifier
interventional
422
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2021
Shorter than P25 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedStudy Start
First participant enrolled
June 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2022
CompletedSeptember 27, 2022
September 1, 2022
1.2 years
February 5, 2021
September 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
16 Week
Study Arms (2)
IMC-1 Oral Tablet
EXPERIMENTAL2X IMC-1 Tablet taken orally, each morning and evening.
Placebo
PLACEBO COMPARATOR2X Placebo Tablet taken orally, each morning and evening.
Interventions
Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any underlying medical or psychiatric condition that could impact their safe participation per protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
IMC Study Site
Birmingham, Alabama, 35216, United States
IMC Study Site
Rogers, Arkansas, 72758, United States
IMC Study Site
Oceanside, California, 92056, United States
IMC Study Site
Riverside, California, 92503, United States
IMC Study Site
Sacramento, California, 95831, United States
IMC Study Site
San Diego, California, 92103, United States
IMC Study Site
Santa Ana, California, 92705, United States
IMC Study Site
Temecula, California, 92591, United States
IMC Study Site
Jacksonville, Florida, 32256, United States
IMC Study Site
Ocala, Florida, 34470, United States
IMC Study Site
Oldsmar, Florida, 34677, United States
IMC Study Site
Orlando, Florida, 32801, United States
IMC Study Site
Tampa, Florida, 33614, United States
IMC Study Site
Alpharetta, Georgia, 30022, United States
IMC Study Site
Gurnee, Illinois, 60031, United States
IMC Study Site
Evansville, Indiana, 47714, United States
IMC Study Site
Des Moines, Iowa, 50265, United States
IMC Study SIte
Prairie Village, Kansas, 66208, United States
IMC Study Site
Covington, Louisiana, 70433, United States
IMC Study Site
New Orleans, Louisiana, 70124, United States
IMC Study Site
Prairieville, Louisiana, 70769, United States
IMC Study Site
Boston, Massachusetts, 02131, United States
IMC Study Site
North Dartmouth, Massachusetts, 02747, United States
IMC Study Site
Jackson, Mississippi, 39202, United States
IMC Study Site
Las Vegas, Nevada, 89102, United States
IMC Study Site
Albuquerque, New Mexico, 87109, United States
IMC Study Site
Cedarhurst, New York, 11516, United States
IMC Study Site
Williamsville, New York, 14221, United States
IMC Study Site
Cincinnati, Ohio, 45219, United States
IMC Study Site
North Canton, Ohio, 44720, United States
IMC Study Site
Oklahoma City, Oklahoma, 73106, United States
IMC Study Site
Tulsa, Oklahoma, 74133, United States
IMC Study Site
Portland, Oregon, 97210, United States
IMC Study Site
Allentown, Pennsylvania, 18104, United States
IMC Study Site
Warwick, Rhode Island, 02886, United States
IMC Study Site
Chattanooga, Tennessee, 37421, United States
IMC Study Site
Knoxville, Tennessee, 37912, United States
IMC Study Site
Austin, Texas, 78737, United States
IMC Study Site
Dallas, Texas, 75231, United States
IMC Study Site
Salt Lake City, Utah, 84102, United States
IMC Study Site
Charlottesville, Virginia, 22911, United States
IMC Study Site
Everett, Washington, 98201, United States
Related Publications (1)
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.
PMID: 28260944BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2021
First Posted
February 10, 2021
Study Start
June 3, 2021
Primary Completion
August 5, 2022
Study Completion
August 5, 2022
Last Updated
September 27, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share
No: There is not a plan to make IPD available.