FibromyalgiaPhase 2FORTRESSNCT04748705
Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1
A Phase 2 study testing IMC-1 in people with Fibromyalgia, run by Virios Therapeutics, Inc. at 42 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- IMC-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 42 sitesUnited States
- Study dates
- 3 Jun 2021to 5 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any underlying medical or psychiatric condition that could impact their safe participation per protocol.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
IMC Study Site
Albuquerque, New Mexico, 87109
IMC Study Site
Allentown, Pennsylvania, 18104
IMC Study Site
Alpharetta, Georgia, 30022
IMC Study Site
Austin, Texas, 78737
IMC Study Site
Birmingham, Alabama, 35216
IMC Study Site
Boston, Massachusetts, 02131
IMC Study Site
Cedarhurst, New York, 11516
IMC Study Site
Charlottesville, Virginia, 22911
IMC Study Site
Chattanooga, Tennessee, 37421
IMC Study Site
Cincinnati, Ohio, 45219
IMC Study Site
Covington, Louisiana, 70433
IMC Study Site
Dallas, Texas, 75231
IMC Study Site
Des Moines, Iowa, 50265
IMC Study Site
Evansville, Indiana, 47714
IMC Study Site
Everett, Washington, 98201
IMC Study Site
Gurnee, Illinois, 60031
IMC Study Site
Jackson, Mississippi, 39202
IMC Study Site
Jacksonville, Florida, 32256
IMC Study Site
Knoxville, Tennessee, 37912
IMC Study Site
Las Vegas, Nevada, 89102
IMC Study Site
New Orleans, Louisiana, 70124
IMC Study Site
North Canton, Ohio, 44720
IMC Study Site
North Dartmouth, Massachusetts, 02747
IMC Study Site
Ocala, Florida, 34470
IMC Study Site
Oceanside, California, 92056
IMC Study Site
Oklahoma City, Oklahoma, 73106
IMC Study Site
Oldsmar, Florida, 34677
IMC Study Site
Orlando, Florida, 32801
IMC Study Site
Portland, Oregon, 97210
IMC Study SIte
Prairie Village, Kansas, 66208
IMC Study Site
Prairieville, Louisiana, 70769
IMC Study Site
Riverside, California, 92503
IMC Study Site
Rogers, Arkansas, 72758
IMC Study Site
Sacramento, California, 95831
IMC Study Site
Salt Lake City, Utah, 84102
IMC Study Site
San Diego, California, 92103
IMC Study Site
Santa Ana, California, 92705
IMC Study Site
Tampa, Florida, 33614
IMC Study Site
Temecula, California, 92591
IMC Study Site
Tulsa, Oklahoma, 74133
IMC Study Site
Warwick, Rhode Island, 02886
IMC Study Site
Williamsville, New York, 14221
About this study
Official title: A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia
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.
- Conditions
- Fibromyalgia
- Being tested
- IMC-1, Placebo BID Tablet
- Keywords
- Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-1Drug
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 BID TabletDrug
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 group | Role | What they receive |
|---|---|---|
| IMC-1 Oral Tablet | Experimental | 2X IMC-1 Tablet taken orally, each morning and evening. Receives: Drug: IMC-1 |
| Placebo | Placebo comparator | 2X Placebo Tablet taken orally, each morning and evening. Receives: Drug: Placebo BID Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start3 Jun 2021
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virios Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748705
- Sponsor's protocol ID
- PRID-202
- Acronym
- FORTRESS
- Status last verified
- Sep 2022
- First submitted
- 5 Feb 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No: There is not a plan to make IPD available.
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.
PubMed 28260944
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT04748705
- Acronym / sponsor ID
- FORTRESS / PRID-202
- Conditions
- Fibromyalgia
- Keywords
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Virios Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMC-1 Oral Tablet | Experimental | Drug: IMC-12X IMC-1 Tablet taken orally, each morning and evening. |
| Placebo | Placebo comparator | Drug: Placebo BID Tablet2X Placebo Tablet taken orally, each morning and evening. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Any underlying medical or psychiatric condition that could impact their safe participation per protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMC-1Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration. | Drug | IMC-1 Oral Tablet |
| Placebo BID TabletPatients 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 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Background: PubMed 28260944Pridgen 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.
- Individual participant dataSharing planned: No. No: There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMC-1 in people with Fibromyalgia, run by Virios Therapeutics, Inc. at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Pain Score (time frame: 16 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04748705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.