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

3 1

What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Hippokration Hospital	Athens	Greece
Aajzlzk Oemcxhzwcti Uhdghwtudyzst Ctmajpqrjngz Ddgrm Szsauq E Dctki Svpoowl Db Thspub	Turin	Italy

Trial status

Country	Status	Recruitment Start
Greece	Not yet recruiting	30.04.2025
Italy	Not yet recruiting	30.04.2025

Trial locations

Investigated drugs:

Cannabidiol

Based on the provided trial information, I can identify the following medications:

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.

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 ID:

2024-517688-21-00

Protocol code:

100-006

NCT ID:

NCT06708299

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?