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Study of cannabidiol (CardiolRx) in patients with recurrent pericarditis after stopping IL-1 blocker treatment

Verified siteInvestigational
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with recurrent pericarditis, a condition where the protective covering around the heart becomes inflamed repeatedly. The study will test a medication called CardiolRx, which contains cannabidiol as its active ingredient, in patients who are currently being treated with IL-1 blockers (medications that reduce inflammation) and are ready to stop this treatment.

The purpose of this research is to determine if patients who are dependent on IL-1 blockers can successfully stop their current treatment while taking CardiolRx without experiencing another episode of pericarditis. The study will compare CardiolRx with placebo over a period of 24 weeks (6 months). Both CardiolRx and the placebo will be given as oral solutions.

During the study, participants will be monitored for signs of pericarditis returning, which includes checking for chest pain and measuring levels of C-Reactive Protein (a substance in the blood that indicates inflammation) in their blood. The medication will be given daily, with doses calculated based on the patient's weight, up to a maximum of 20 milligrams per kilogram per day.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility will be evaluated based on being at least 18 years old and having a history of recurrent pericarditis (inflammation of the heart lining) with stable condition.

    Your pain level must be 2 or lower on a scale of 0-10 for the week before starting.

    Your C-Reactive Protein (CRP) level must be less than 1.0 mg/dL in the week before starting.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either CardiolRx (containing cannabidiol) or a placebo solution.

    The medication will be taken by mouth.

    Your current IL-1 blocker medication will be discontinued.

  3. Step 3

    Treatment period

    The treatment period lasts for 24 weeks (approximately 6 months).

    Regular assessments will include pain measurements using a 0-10 scale.

    Blood tests will be performed to check your CRP levels.

    Your heart function will be monitored through ECG (heart rhythm test).

    Laboratory tests will check your liver function and blood clotting.

  4. Step 4

    Monitoring for recurrence

    A recurrence is defined as having pain level of 4 or higher on a 0-10 scale.

    A blood test showing CRP level of 1.0 mg/dL or higher must also be present within 7 days of the pain.

    Key checkpoints will occur at week 8 and week 24 of the study.

  5. Step 5

    Safety monitoring

    Throughout the study, you will be monitored for any side effects or adverse reactions.

    Regular safety assessments will include blood tests and heart monitoring.

    Your mental health status will be evaluated using a standardized questionnaire.

Who can join the trial?

15 criteria

  • Must be 18 years of age or older
  • Must have a history of recurrent pericarditis (repeated inflammation of the heart lining) with stable condition and currently receiving IL-1 blocker treatment that is planned to be discontinued
  • Must have been on IL-1 blocker treatment for at least 12 months
  • Must be free from pericarditis recurrence for at least 6 months
  • Must have been on a stable, unchanged dose of IL-1 blocker for at least 3 months before starting the study
  • Must have pain levels of 2 or less on a 0-10 scale for 7 days before starting the study
  • Must have C-Reactive Protein (CRP) levels less than 1.0 mg/dL (CRP is a blood test that measures inflammation) within 7 days before starting the study
  • For male participants: must either have had a vasectomy or agree to use double barrier contraception during the study and for 2 months after
  • For women who can become pregnant: must use approved contraception methods during the study and for 2 months after, or be post-menopausal (no menstrual periods for at least 1 year), or be surgically sterile
  • Approved contraception methods include:
    • Hormonal contraceptives (pills, patches, or vaginal rings)
    • Injectable or implantable contraceptives
    • Intrauterine devices (IUD)
    • Bilateral tubal occlusion
    • Partner with vasectomy
    • Sexual abstinence

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions to medications or active substances
  • Presence of active infections or ongoing infectious diseases
  • Diagnosed tuberculosis or positive test for tuberculosis
  • Liver disease or abnormal liver function tests
  • Kidney disease or significantly reduced kidney function
  • Uncontrolled high blood pressure
  • History of heart attack or stroke within the past 6 months
  • Current diagnosis of cancer or ongoing cancer treatment
  • Pregnancy, planning pregnancy, or breastfeeding
  • Participation in other clinical trials within the past 30 days
  • Use of prohibited medications that might interfere with the study drug
  • Inability to follow study procedures or attend scheduled visits
  • History of substance abuse within the past year
  • Significant mental health conditions that could affect participation
  • Any condition that the study doctor believes would make participation unsafe
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Investigated drugs

  • CardiolRx

    is an experimental medication being studied for treating recurrent pericarditis (inflammation of the heart lining). It is being tested in patients who were previously dependent on IL-1 blocker therapy to see if it can help prevent inflammation from returning after stopping their previous treatment.

  • IL-1 blocker

    is a type of medication that works by blocking a protein called interleukin-1, which is involved in inflammation. This medication was previously used to treat patients with recurrent pericarditis, and the study aims to see if patients can stop using it while taking CardiolRx instead.

What is already known about the treatment

CardiolRx - An investigational medication being studied for the treatment of recurrent pericarditis, particularly in patients who are dependent on IL-1 blockers. This pharmaceutical compound is being evaluated in clinical trials to determine its effectiveness in allowing patients to discontinue IL-1 blocker therapy while preventing disease recurrence. The medication is currently undergoing controlled clinical trials to assess both its efficacy and safety profile, with a specific focus on demonstrating tolerability in the target patient population. While the exact mechanism of action and administration form are not specified in the available trial data, the medication is being studied as a potential therapeutic option for managing inflammatory conditions of the pericardium. Note: Since IL-1 blockers are mentioned in the context but are not the primary investigational drug, I have focused the description on CardiolRx, which is the main study medication in this clinical trial.

Investigated diseases

Recurrent Pericarditis - A condition where inflammation of the pericardium (the outer covering of the heart) occurs repeatedly after an initial episode. The condition is characterized by chest pain that typically worsens when lying down or taking deep breaths. Episodes of inflammation can come back weeks or months after the initial occurrence. During active episodes, patients may experience fever and feel generally unwell. The condition involves elevated levels of inflammatory markers in the blood, particularly C-reactive protein (CRP).
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517688-21-00Protocol code100-006Estimated enrolment110 patientsSponsorCardiol Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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