Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot) (NCT05494788) | Clinical Trial Compass
CompletedPhase 2
Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)
United States27 participantsStarted 2023-01-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
. 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