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History of Changes for Study: NCT04748705
A Phase 2b Study To Evaluate The Efficacy And Safety Of IMC-1 BID In Patients With Fibromyalgia
Latest version (submitted September 25, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 5, 2021 None (earliest Version on record)
2 May 10, 2021 Study Status, Eligibility, Study Identification and IPDSharing
3 May 24, 2021 Oversight, References, Contacts/Locations, Eligibility and Study Status
4 June 4, 2021 Recruitment Status, Study Status and Contacts/Locations
5 June 24, 2021 Contacts/Locations and Study Status
6 August 18, 2021 Arms and Interventions and Study Status
7 May 13, 2022 Recruitment Status, Contacts/Locations and Study Status
8 September 25, 2022 Recruitment Status, Study Status and Study Design
Comparison Format:

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Study NCT04748705
Submitted Date:  February 5, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: PRID-202
Brief Title: A Phase 2b Study To Evaluate The Efficacy And Safety Of IMC-1 BID In Patients With Fibromyalgia
Official Title: A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2021
Overall Status: Not yet recruiting
Study Start: April 2021
Primary Completion: June 2022 [Anticipated]
Study Completion: July 2022 [Anticipated]
First Submitted: February 5, 2021
First Submitted that
Met QC Criteria:
February 5, 2021
First Posted: February 10, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
February 5, 2021
Last Update Posted: February 10, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Virios Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Fibromyalgia
Keywords: Pain
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 460 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: IMC-1 Oral Tablet
2X IMC-1 Tablet taken orally, each morning and evening.
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.
Placebo Comparator: Placebo
2X Placebo Tablet taken orally, each morning and evening.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • The patient is male or 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.
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Not Decided, will update.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services