Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)

NCT05494788 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Cardiol 100-004
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

Recurrent Pericarditis

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Other Outcomes (6)

• Pericarditis Recurrence During the Extension Period (EP)

  18 weeks

• CRP Change From Baseline

  26 weeks

• Percentage of Patients With Normalized CRP Levels

  26 weeks

Study Arms (1)

CardiolRx

EXPERIMENTAL

pharmaceutically produced Cannabidiol

Drug: CardiolRx

Interventions

CardiolRx DRUG

Oral solution

Also known as: Pharmaceutically produced Cannabidiol

CardiolRx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Cardiol Therapeutics Inc.: lead

Study Sites (8)

Pima Heart and Vascular Clinical Research

Tucson, Arizona, 85719, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Virginia Commonwealth University Health

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

• 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.

  PMID: 26320112 BACKGROUND

• Klein 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.

  PMID: 33200890 BACKGROUND

MeSH Terms

Conditions

Pericarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

In terms of limitations, this study was an open label, single-arm study so there was no control group. The number of patients included was also small but considered a sufficient sample size to demonstrate both the efficacy and safety objectives of this pilot study.

Results Point of Contact

• Title: Andrea B. Parker, MSc., PhD, Senior Director of Clinical Operations
• Organization: Cardiol Therapeutics Inc.

andrea.parker@cardiolrx.com

+1 289 9100862

Study Officials

• Allen Klein, MD

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: January 9, 2023
• Primary Completion: June 15, 2024
• Study Completion: September 6, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)