Recurrent PericarditisPhase 2NCT05494788
Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)
A Phase 2 study testing CardiolRx in people with Recurrent Pericarditis, run by Cardiol Therapeutics Inc. at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Pericarditis
- What is being tested?
- CardiolRx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 8 sitesUnited States
- Study dates
- 9 Jan 2023to 6 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or older
- Diagnosis of at least two episodes of recurrent pericarditis*,
- At least 1 day with pericarditis pain ≥4 on the 11-point Numerical Rating Scale (NRS) within prior 7 days
- One of;
- C-Reactive Protein** (CRP) level ≥1.0 mg/dL within prior 7 days OR
- Evidence of pericardial inflammation assessed by delayed pericardial hyperenhancement on cardiac magnetic resonance imaging (CMR)
Show all 16Show fewer
- Currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids (in any combination) for treatment of pericarditis in stable doses
- Male patients with partners of childbearing potential who have had a vasectomy or are willing to use double barrier contraception methods during the conduct of the study and for 2 months after the last dose of study drug.
- 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 postmenopausal (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.
- Diagnosis of pericarditis according to the 2015 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler et al. 2015):
- At least two of:
- Pericarditic chest pain
- Pericardial rub
- New widespread ST-segment elevation or PR-segment depression according to electrocardiogram (ECG) findings
- Pericardial effusion (new or worsening)
- Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP
Who cannot join
- Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); myocarditis
- Estimated glomerular filtration rate (eGFR) <30 mL/min at screening
- Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN
- Sepsis, defined as documented bacteremia at the time of screening or other documented active infection
- Prior history of sustained ventricular arrhythmia
- History of QT interval prolongation
Show all 24Show fewer
- QTc interval > 500 msec
- Current participation in any research study involving investigational drugs or device
- Inability or unwillingness to give informed consent
- Ongoing drug or alcohol abuse
- On any cannabinoid during the past month
- Women who are pregnant or breastfeeding
- Current diagnosis of cancer, with the exception of non-melanoma skin cancer
- Any factor, which would make it unlikely that the patient can comply with the study procedures
- Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS), administered at screening
- On digoxin and/or type 1 or 3 antiarrhythmics
- On immunosuppressive therapy with any of the following:
- Rilonacept
- Anakinra
- Canakinumab
- Methotrexate
- Azathioprine
- Cyclosporine
- Intravenous immune globulin (IVIG)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Vermont Medical Center
Burlington, Vermont, 05401
Cleveland Clinic
Cleveland, Ohio, 44195
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Virginia Commonwealth University Health
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Pima Heart and Vascular Clinical Research
Tucson, Arizona, 85719
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Impact of CardiolRxTM on Recurrent Pericarditis An Open Label Pilot Study (MAvERIC-Pilot Study)
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.
Read the detailed description
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
- Day 3 p.m. dose to Day 10 a.m. dose: 7.5 mg/kg of body weight CardiolRxTM b.i.d.
- Day 10 p.m. dose to end of treatment period: 10.0 mg/kg of body weight CardiolRxTM b.i.d.
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.
- Conditions
- Recurrent Pericarditis
- Being tested
- CardiolRx
- Medical subject headings
- Pericarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiolRxDrug
Also called Pharmaceutically produced Cannabidiol
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| CardiolRx | Experimental | pharmaceutically produced Cannabidiol Receives: Drug: CardiolRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start9 Jan 2023
- Primary completion15 Jun 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recurrent PericarditisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiol Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allen Klein, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494788
- Sponsor's protocol ID
- Cardiol 100-004
- Status last verified
- Oct 2025
- First submitted
- 8 Aug 2022
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adler Y, Charron P, Imazio M, Badano L, Baron-Esquivias G, Bogaert J, Brucato A, Gueret P, Klingel K, Lionis C, Maisch B, Mayosi B, Pavie A, Ristic AD, Sabate Tenas M, Seferovic P, Swedberg K, Tomkowski W; ESC Scientific Document Group. 2015 ESC Guidelines for the diagnosis and management of pericardial diseases: The Task Force for the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology (ESC)Endorsed by: The European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2015 Nov 7;36(42):2921-2964. doi: 10.1093/eurheartj/ehv318. Epub 2015 Aug 29. No abstract available.
PubMed 26320112Klein AL, Imazio M, Cremer P, Brucato A, Abbate A, Fang F, Insalaco A, LeWinter M, Lewis BS, Lin D, Luis SA, Nicholls SJ, Pano A, Wheeler A, Paolini JF; RHAPSODY Investigators. Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis. N Engl J Med. 2021 Jan 7;384(1):31-41. doi: 10.1056/NEJMoa2027892. Epub 2020 Nov 16.
PubMed 33200890Luis SA, Klein AL, Cremer PC, Abbate A, Salik JR, Thomas GK, Haider SW, Hagerty TE, Lin D, Waggoner TE, Nicholls SJ, Kirwan BA, Narine KAD, Parker AB, Hamer A. Efficacy and Safety of Pharmaceutically Manufactured Cannabidiol in Recurrent Pericarditis: A Phase II Clinical Trial. J Am Heart Assoc. 2026 Jul 21;15(14):e047605. doi: 10.1161/JAHA.125.047605. Epub 2026 Jul 10.
PubMed 42432451
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CardiolRxTM on Recurrent Pericarditis An Open Label Pilot Study (MAvERIC-Pilot Study)
- ClinicalTrials.gov ID
- NCT05494788
- Acronym / sponsor ID
- Cardiol 100-004
- Conditions
- Recurrent Pericarditis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cardiol Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Day 3 p.m. dose to Day 10 a.m. dose: 7.5 mg/kg of body weight CardiolRxTM b.i.d.
- Day 10 p.m. dose to end of treatment period: 10.0 mg/kg of body weight CardiolRxTM b.i.d.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| CardiolRx | Experimental | Drug: CardiolRxpharmaceutically produced Cannabidiol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female 18 years of age or older
- Diagnosis of at least two episodes of recurrent pericarditis*,
- At least 1 day with pericarditis pain ≥4 on the 11-point Numerical Rating Scale (NRS) within prior 7 days
- One of;
- Currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids (in any combination) for treatment of pericarditis in stable doses
Key exclusion criteria (24 listed)
- Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); myocarditis
- Estimated glomerular filtration rate (eGFR) <30 mL/min at screening
- Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN
- Sepsis, defined as documented bacteremia at the time of screening or other documented active infection
- Prior history of sustained ventricular arrhythmia
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 |
|---|---|---|
| CardiolRxAlso: Pharmaceutically produced CannabidiolOral solution | Drug | CardiolRx |
Primary outcome
11-point NRS Pain Score
Time frame: 8 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26320112Adler Y, Charron P, Imazio M, Badano L, Baron-Esquivias G, Bogaert J, Brucato A, Gueret P, Klingel K, Lionis C, Maisch B, Mayosi B, Pavie A, Ristic AD, Sabate Tenas M, Seferovic P, Swedberg K, Tomkowski W; ESC Scientific Document Group. 2015 ESC Guidelines for the diagnosis and management of pericardial diseases: The Task Force for the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology (ESC)Endorsed by: The European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2015 Nov 7;36(42):2921-2964. doi: 10.1093/eurheartj/ehv318. Epub 2015 Aug 29. No abstract available.
- Background: PubMed 33200890Klein AL, Imazio M, Cremer P, Brucato A, Abbate A, Fang F, Insalaco A, LeWinter M, Lewis BS, Lin D, Luis SA, Nicholls SJ, Pano A, Wheeler A, Paolini JF; RHAPSODY Investigators. Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis. N Engl J Med. 2021 Jan 7;384(1):31-41. doi: 10.1056/NEJMoa2027892. Epub 2020 Nov 16.
- Derived from this study: PubMed 42432451Luis SA, Klein AL, Cremer PC, Abbate A, Salik JR, Thomas GK, Haider SW, Hagerty TE, Lin D, Waggoner TE, Nicholls SJ, Kirwan BA, Narine KAD, Parker AB, Hamer A. Efficacy and Safety of Pharmaceutically Manufactured Cannabidiol in Recurrent Pericarditis: A Phase II Clinical Trial. J Am Heart Assoc. 2026 Jul 21;15(14):e047605. doi: 10.1161/JAHA.125.047605. Epub 2026 Jul 10.
- Individual participant dataSharing planned: No
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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.
Allen Klein, MD study chair
The Cleveland Clinic
8 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 CardiolRx in people with Recurrent Pericarditis, run by Cardiol Therapeutics Inc. at 8 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 16 inclusion and 24 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
11-point NRS Pain Score (time frame: 8 weeks). 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 NCT05494788, which also lists 3 linked publications.
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 20 Oct 2025.