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

Virios Therapeutics

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: IMC-1; Drug: Placebo BID Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04748705

PRID-202

Details and patient eligibility

About

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.

Enrollment: 422 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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422 participants in 2 patient groups, including a placebo group

IMC-1 Oral Tablet

Experimental group

Description:

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

Treatment:

Drug: IMC-1

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo BID Tablet