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

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ClinicalTrials.gov Identifier: NCT04748705
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Virios Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE February 5, 2021
First Posted Date  ICMJE February 10, 2021
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE June 3, 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1
Official Title  ICMJE A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: INC-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.
  • 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.
Study Arms  ICMJE
  • Experimental: IMC-1 Oral Tablet
    2X IMC-1 Tablet taken orally, each morning and evening.
    Intervention: Drug: INC-1
  • Placebo Comparator: Placebo
    2X Placebo Tablet taken orally, each morning and evening.
    Intervention: Drug: Placebo BID Tablet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2021)
460
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Channing Gray, MS (866)-620-8655 info@virios.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04748705
Other Study ID Numbers  ICMJE PRID-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No: There is not a plan to make IPD available.
Responsible Party Virios Therapeutics, Inc.
Study Sponsor  ICMJE Virios Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Virios Therapeutics, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP