CardiolRx for Pericarditis
(MAVERIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CardiolRx for individuals with recurrent pericarditis, a condition where the sac around the heart becomes inflamed repeatedly. The goal is to determine if participants can remain free of pericarditis flare-ups while taking CardiolRx after stopping their current IL-1 blocker medication. Participants should have managed their pericarditis with an IL-1 blocker for at least a year and remained stable without flare-ups for at least six months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
Participants will need to stop taking their IL-1 blocker as part of the trial. The trial does not specify if other medications need to be stopped, but certain immunomodulatory agents must not have been used recently before joining the trial.
Is there any evidence suggesting that CardiolRx is likely to be safe for humans?
Studies have shown that CardiolRx is safe and well tolerated. In earlier trials with patients who had serious health issues, CardiolRx did not cause major safety problems. Participants managed the treatment well, with no significant side effects.
These findings suggest that CardiolRx could be a good option for those considering joining a trial, as the treatment appears safe based on previous research.12345Why do researchers think this study treatment might be promising?
Researchers are excited about CardiolRx for pericarditis because it offers a potential new approach by utilizing cannabidiol (CBD) as its active ingredient. Unlike standard treatments like NSAIDs, colchicine, or corticosteroids, which primarily focus on reducing inflammation, CardiolRx targets both inflammation and the underlying processes that contribute to the condition, potentially offering a more comprehensive benefit. Additionally, CardiolRx is administered in a gradually increasing dose regimen, which might help optimize its effectiveness and minimize side effects, making it a promising alternative for those who may not respond well to current treatments.
What evidence suggests that CardiolRx might be an effective treatment for pericarditis?
Research has shown that CardiolRx, which participants in this trial may receive, offers promising results for people with recurring pericarditis. Earlier studies found that CardiolRx significantly reduced pain and swelling reported by patients. The treatment proved safe and easy to tolerate, which is important for long-term use. These findings suggest that CardiolRx could help prevent future episodes of pericarditis, offering hope to those affected by this condition.12467
Who Is on the Research Team?
Paul Cremer, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for patients with recurrent pericarditis who have been on an IL-1 blocker for at least a year and are planning to stop the medication. They will be part of a study that tests if CardiolRx can prevent their pericarditis from coming back after stopping the IL-1 blocker.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive double-blind trial therapy with CardiolRx or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CardiolRx
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cardiol Therapeutics Inc.
Lead Sponsor