A Phase 2 interventional study of CardiolRx in Recurrent Pericarditis, sponsored by Cardiol Therapeutics Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by Cardiol Therapeutics Inc. · Phase 2, Interventional, and Treatment
Patients with recurrent pericarditis who are refractory or intolerant to current therapeutic management options or who require long-term administration of corticosteroids to control their disease are particularly challenging to manage. The pathogenesis of pericarditis involves the activation of the inflammasome. CardiolRxTM (a pure cannabidiol [CBD] solution) is known to have anti-inflammatory properties, including modulation of inflammasome signaling. This pilot study is to assess the tolerance and safety of CardiolRxTM during the resolution of pericarditis symptoms, assess improvement in objective measures of disease, and during the extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids while taking CardiolRxTM.
Multi-center, open label Pilot Study. Patients who present with recurrent pericarditis will be screened and informed consent obtained.
Baseline assessments include the following: Clinical assessment, including vital signs, highest NRS pain score within the past 7 days of Day 1, 12-lead ECG; C-SSRS as well as hematology and blood chemistry and a pregnancy test for women with child-bearing potential.
Concomitant medications are recorded and any (S)AEs after informed consent has been obtained.
Study treatment will be initiated in the evening of Day 1, after all baseline assessments are completed.
Oral administration is as follows:
Initial starting dose (Day 1 p.m. dose to Day 3 a.m. dose):
5 mg/kg of body weight CardiolRxTM
If the next higher dose after each study drug increase is not tolerated, the dose will be reduced to the previous tolerated dose.
Unless contraindicated in the opinion of the investigator, after 8 weeks of treatment, patients will enter an 18-week extension period (EP), in which they continue study treatment while their concomitant medications will be weaned.
Follow-up Procedures Every visit (before the next dose increase) the patient will be re-evaluated. This includes ECG monitoring at approximately 5 hours post-morning dose (Tmax) to surveil for deleterious effects on ECG intervals (particularly the QTc interval) and rhythm.
Drug titration will be dependent on investigator or designate interrogation of the ECGs and the absence of new, clinically significant abnormalities on those ECGs.
Vital signs, concurrent medication and (S)AEs will be recorded at all visits. Blood chemistry including liver function tests, hematology as well as INR assessments will be carried out at selected visits.
Final efficacy assessments will take place after 26 weeks of study treatment and include a clinical assessment, vital signs, pain score NRS, a 12-lead ECG, the C-SSRS, as well as laboratory assessments.
For patients who do not enter the EP, Final assessments will be done after 8 weeks.
54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 29 interventional studies indexed under Pericarditis.
Browse Pericarditis studies →Cardiol Therapeutics Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
One of;
Women of childbearing potential willing to use an acceptable method of contraception starting with study drug administration and for a minimum of 2 months after study completion. Otherwise, women must be (at least 1 y absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone [FSH] ≥40 mIU/mL [or ≥ 40 IU/L] if less than 2 y postmenopausal) or be surgically sterile.
At least two of:
Pericardial effusion (new or worsening)
Exclusion Criteria:
On therapy with any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
pharmaceutically produced Cannabidiol
Drug: CardiolRx
Oral solution
Also known as: Pharmaceutically produced Cannabidiol
11-point NRS Pain Score
Change in pain score from baseline using 11-point NRS after 8 weeks of treatment. Nominal Rating Scale from 0 to 10, where 0 represents no pain and 10 maximum pain.
Time frame: 8 weeks
Pericarditis Recurrence During the Extension Period (EP)
Percentage of patients with pericarditis recurrence during the extension period (EP)
Time frame: 18 weeks
CRP Change From Baseline
CRP change from baseline, as measured locally at baseline and at weeks 8, 16, and 26.
Time frame: 26 weeks
Percentage of Patients With Normalized CRP Levels
Percentage of patients with normalized CRP levels at 26 weeks (for patients with CRP ≥ 1.0 mg/dL at baseline)
Time frame: 26 weeks
Percentage of Patients With Normalized CRP Levels
Percentage of patients with normalized CRP levels at 8 weeks (for patients with CRP ≥1.0 mg/dL at baseline)
Time frame: 8 weeks
Time to Normalized CRP Levels
Time to CRP normalization for patients with CRP ≥1.0 mg/dL at baseline
Time frame: Over 26 weeks
11-point NRS Pain Score
Change in pain score from baseline using 11-point NRS after 26 weeks of treatment. Nominal Rating Scale from 0 to 10, where 0 represents no pain and 10 maximum pain.
Time frame: 26 weeks
First patient enrolled on January 9, 2023; Last patient last visit on September 6, 2024
| Milestone | CardiolRx |
|---|---|
| Started | 27 |
| Completed | 24 |
| Not completed | 3 |
| Withdrew: Adverse event | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | CardiolRx |
|---|---|
| Started | 24 |
| Completed | 22 |
| Not completed | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
Change in pain score from baseline using 11-point NRS after 8 weeks of treatment. Nominal Rating Scale from 0 to 10, where 0 represents no pain and 10 maximum pain.
| units on a scale | CardiolRx |
|---|---|
| 11-point NRS Pain Score | -3.7 ± 2.07 |
Percentage of patients with pericarditis recurrence during the extension period (EP)
| Participants | CardiolRx |
|---|---|
| Pericarditis Recurrence During the Extension Period (EP) | 7 |
CRP change from baseline, as measured locally at baseline and at weeks 8, 16, and 26.
| mg/dl | CardiolRx |
|---|---|
| CRP Change From Baseline | 0.07 ± 0.10 |
Percentage of patients with normalized CRP levels at 26 weeks (for patients with CRP ≥ 1.0 mg/dL at baseline)
| Participants | CardiolRx |
|---|---|
| Percentage of Patients With Normalized CRP Levels | 7 |
Percentage of patients with normalized CRP levels at 8 weeks (for patients with CRP ≥1.0 mg/dL at baseline)
| Participants | CardiolRx |
|---|---|
| Percentage of Patients With Normalized CRP Levels | 7 |
Time to CRP normalization for patients with CRP ≥1.0 mg/dL at baseline
| days | CardiolRx |
|---|---|
| Time to Normalized CRP Levels | 26.4 ± 18.46 |
Change in pain score from baseline using 11-point NRS after 26 weeks of treatment. Nominal Rating Scale from 0 to 10, where 0 represents no pain and 10 maximum pain.
| units on a scale | CardiolRx |
|---|---|
| 11-point NRS Pain Score | 4.3 ± 2.46 |
Collected over Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CardiolRx | 0/27 (0%) | 1/27 (3.7%) | 14/27 (51.9%) |
| Event | CardiolRx |
|---|---|
| Chest painGeneral disorders | 1/27 |
| ENTERITIS INFECTIOUSInfections and infestations | 1/27 |
| Tooth fractureInjury, poisoning and procedural complications | 1/27 |
| DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMSSkin and subcutaneous tissue disorders | 1/27 |
| Event | CardiolRx |
|---|---|
| DiarrhoeaGastrointestinal disorders | 14/27 |
| Chest painGeneral disorders | 10/27 |
| PericarditisCardiac disorders | 8/27 |
| RashSkin and subcutaneous tissue disorders | 7/27 |
| NauseaGastrointestinal disorders | 5/27 |
| FatigueGeneral disorders | 5/27 |
| Upper respiratory tract infectionInfections and infestations | 5/27 |
| Abdominal discomfortGastrointestinal disorders | 4/27 |
| HeadacheNervous system disorders | 4/27 |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONSInjury, poisoning and procedural complications | 3/27 |
| Age, Continuous(years) | CardiolRx |
|---|---|
| Mean | 52.7 ± 14.96 |
| Sex: Female, Male(Participants) | CardiolRx |
|---|---|
| Female | 18 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | CardiolRx |
|---|---|
| Hispanic or Latino | 27 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | CardiolRx |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | CardiolRx |
|---|---|
| United States | 27 |
| NRS Scores (Outcome measure 1)(units on a scale) | CardiolRx |
|---|---|
| Mean | 5.8 ± 1.71 |
| CRP(mg/dl) | CardiolRx |
|---|---|
| Mean | 4.44 ± 7.21 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Cannabidiol
Cardiol Therapeutics Inc.