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

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

Tracking Information

• First Submitted Date: February 5, 2021
• First Posted Date: February 10, 2021
• Last Update Posted Date: June 7, 2021
• Actual Study Start Date: June 3, 2021
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Fibromyalgia

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 5, 2021): 460
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2022
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Channing Gray, MS; (866)-620-8655; info@virios.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04748705
• Other Study ID Numbers: 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

• Plan to Share IPD: No
• Plan Description: No: There is not a plan to make IPD available.

• Responsible Party: Virios Therapeutics, Inc.
• Study Sponsor: Virios Therapeutics, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Virios Therapeutics, Inc.
• Verification Date: May 2021