[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570519":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":403,"collaborators":36,"id":405,"slug":406,"hasResults":407,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":407,"sex":413,"minAge":414,"maxAge":36,"enrollmentInfo":415,"targetDuration":36,"studyType":418,"phases":419,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":45,"whyStopped":36,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},{"fullName":5,"class":6},"Cardiol Therapeutics Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CardiolRx","ACTIVE_COMPARATOR","* Initial starting dose (Day 1, evening dose to Day 3, morning dose):\n\n  5 mg\u002Fkg of body weight CardiolRx b.i.d.\n* Day 3, evening dose to Day 10, morning dose: 7.5 mg\u002Fkg of body weight CardiolRx b.i.d.\n* Day 10, evening dose to morning dose of the Week 24 Visit:\n\n  10 mg\u002Fkg of body weight CardiolRx b.i.d.",[13],"Drug: CardiolRx",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","* Initial starting dose (Day 1, evening dose to Day 3, morning dose):\n\n  5 mg\u002Fkg of body weight matching placebo b.i.d.\n* Day 3, evening dose to Day 10, morning dose: 7.5 mg\u002Fkg of body weight matching placebo b.i.d.\n* Day 10, evening dose to morning dose of the Week 24 Visit:\n\n  10 mg\u002Fkg of body weight matching placebo b.i.d.",[13],[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","The intervention will be administered orally (via syringe) with food twice daily.",[9,15],[25],"Pharmaceutically produced cannabidiol",[27],{"name":28,"affiliation":29,"role":30},"Paul Cremer, MD","Northwestern University","PRINCIPAL_INVESTIGATOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Andrea B Parker, MSc., PhD","CONTACT","+1 289 910 0862",null,"andrea.parker@cardiolrx.com",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":41},"Heather Dalgleish, MSc.","+1 289 910 0384","heather.dalgleish@cardiolrx.com",[43,61,75,89,102,115,129,142,156,169,183,197,210,223,233,243,257,270,284,298,312,325,339,353,367,379,391],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Mayo Clionic Arizona","RECRUITING","Phoenix","Arizona","85054","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-112.07404,33.44838,{"lat":55,"lon":54},[58],{"name":59,"role":34,"phone":36,"phoneExt":36,"email":60},"Chadi Ayoub, MD","ayoub.chadi@mayo.edu",{"facility":62,"status":45,"city":63,"state":64,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"UCI Health","Irvine","California","92697",{"type":52,"coordinates":67},[68,69],-117.82311,33.66946,{"lat":69,"lon":68},[72],{"name":73,"role":34,"phone":36,"phoneExt":36,"email":74},"Amin Sabet, MD","sabeta1@hs.uci.edu",{"facility":76,"status":77,"city":78,"state":64,"zip":79,"country":49,"countryCode":50,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Altman Clinical and Translational Research Institute","NOT_YET_RECRUITING","La Jolla","92037",{"type":52,"coordinates":81},[82,83],-117.2742,32.84727,{"lat":83,"lon":82},[86],{"name":87,"role":34,"phone":36,"phoneExt":36,"email":88},"Ajit Raisinghani, MD","araisinghani@health.ucsd.edu",{"facility":90,"status":77,"city":91,"state":64,"zip":92,"country":49,"countryCode":50,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Cedars-Sinai Medical Center","Los Angeles","90048",{"type":52,"coordinates":94},[95,96],-118.24368,34.05223,{"lat":96,"lon":95},[99],{"name":100,"role":34,"phone":36,"phoneExt":36,"email":101},"Paul Marano, MD","Paul.Marano@cshs.org",{"facility":103,"status":45,"city":104,"state":64,"zip":105,"country":49,"countryCode":50,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Pacific Heart Institute at Cedars-Sinai","Santa Monica","90404",{"type":52,"coordinates":107},[108,109],-118.49138,34.01949,{"lat":109,"lon":108},[112],{"name":113,"role":34,"phone":36,"phoneExt":36,"email":114},"Rigved Tadwalker, MD","rtadwalkar@pacificheart.com",{"facility":116,"status":45,"city":117,"state":118,"zip":119,"country":49,"countryCode":50,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Mayo Clinic Florida","Jacksonville","Florida","32224",{"type":52,"coordinates":121},[122,123],-81.65565,30.33218,{"lat":123,"lon":122},[126],{"name":127,"role":34,"phone":36,"phoneExt":36,"email":128},"Prajwal Reddy, MD","reddy.prajwal@mayo.edu",{"facility":29,"status":45,"city":130,"state":131,"zip":132,"country":49,"countryCode":50,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Chicago","Illinois","60208",{"type":52,"coordinates":134},[135,136],-87.65005,41.85003,{"lat":136,"lon":135},[139],{"name":140,"role":34,"phone":36,"phoneExt":36,"email":141},"Mohammed Al-Kazaz, MD","mohamed.alkazaz@nm.org",{"facility":143,"status":45,"city":144,"state":145,"zip":146,"country":49,"countryCode":50,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Johns Hopkins University","Baltimore","Maryland","21205",{"type":52,"coordinates":148},[149,150],-76.61219,39.29038,{"lat":150,"lon":149},[153],{"name":154,"role":34,"phone":36,"phoneExt":36,"email":155},"Luigi Adamo, MD","ladamo2@jhmi.edu",{"facility":157,"status":45,"city":158,"state":145,"zip":159,"country":49,"countryCode":50,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"MedStar Health Institute","Columbia","21044",{"type":52,"coordinates":161},[162,163],-76.83942,39.24038,{"lat":163,"lon":162},[166],{"name":167,"role":34,"phone":36,"phoneExt":36,"email":168},"Syed Haider, MD","Waqas.Haider@medstar.net",{"facility":170,"status":45,"city":171,"state":172,"zip":173,"country":49,"countryCode":50,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":52,"coordinates":175},[176,177],-71.05977,42.35843,{"lat":177,"lon":176},[180],{"name":181,"role":34,"phone":36,"phoneExt":36,"email":182},"Jonathan Salik, MD","jsalik@mgh.harvard.edu",{"facility":184,"status":45,"city":185,"state":186,"zip":187,"country":49,"countryCode":50,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Minneapolis Heart Institute","Minneapolis","Minnesota","55407",{"type":52,"coordinates":189},[190,191],-93.26384,44.97997,{"lat":191,"lon":190},[194],{"name":195,"role":34,"phone":36,"phoneExt":36,"email":196},"David Lin, MD","David.Lin@allina.com",{"facility":198,"status":45,"city":199,"state":186,"zip":200,"country":49,"countryCode":50,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Mayo Clinic","Rochester","55905",{"type":52,"coordinates":202},[203,204],-92.4699,44.02163,{"lat":204,"lon":203},[207],{"name":208,"role":34,"phone":36,"phoneExt":36,"email":209},"Sushil A Luis, MD","luis.s@mayo.edu",{"facility":211,"status":45,"city":212,"state":212,"zip":213,"country":49,"countryCode":50,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"NYU Langone Health","New York","10016",{"type":52,"coordinates":215},[216,217],-74.00597,40.71427,{"lat":217,"lon":216},[220],{"name":221,"role":34,"phone":36,"phoneExt":36,"email":222},"Michael Garshick, MD","michael.garshick@nyulangone.org",{"facility":224,"status":45,"city":212,"state":212,"zip":225,"country":49,"countryCode":50,"cosmosGeoPoint":226,"geoPoint":228,"contacts":229},"Columbia University - New York Presbyterian","10032",{"type":52,"coordinates":227},[216,217],{"lat":217,"lon":216},[230],{"name":231,"role":34,"phone":36,"phoneExt":36,"email":232},"Dor Lotan, MD","dl3491@cumc.columbia.edu",{"facility":234,"status":45,"city":212,"state":212,"zip":235,"country":49,"countryCode":50,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"Lenox Hill Hospital","11030",{"type":52,"coordinates":237},[216,217],{"lat":217,"lon":216},[240],{"name":241,"role":34,"phone":36,"phoneExt":36,"email":242},"Dennis Finkielstein, MD","DFinkielstei@northwell.edu",{"facility":244,"status":45,"city":245,"state":246,"zip":247,"country":49,"countryCode":50,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":52,"coordinates":249},[250,251],-81.69541,41.4995,{"lat":251,"lon":250},[254],{"name":255,"role":34,"phone":36,"phoneExt":36,"email":256},"Saberio Lo Presti Vega, MD","LOPRESS2@ccf.org",{"facility":258,"status":45,"city":259,"state":260,"zip":261,"country":49,"countryCode":50,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Houston Methodist Hospital","Houston","Texas","77030",{"type":52,"coordinates":263},[264,265],-95.36327,29.76328,{"lat":265,"lon":264},[268],{"name":269,"role":34,"phone":36,"phoneExt":36,"email":36},"Maan Malahfji, MD",{"facility":271,"status":45,"city":272,"state":273,"zip":274,"country":49,"countryCode":50,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"University of Utah Hospital","Salt Lake City","Utah","84112",{"type":52,"coordinates":276},[277,278],-111.89105,40.76078,{"lat":278,"lon":277},[281],{"name":282,"role":34,"phone":36,"phoneExt":36,"email":283},"Libo Wang, MD","Libo.Wang@utah.edu",{"facility":285,"status":45,"city":286,"state":287,"zip":288,"country":49,"countryCode":50,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"University of Vermont","Burlington","Vermont","05401",{"type":52,"coordinates":290},[291,292],-73.21207,44.47588,{"lat":292,"lon":291},[295],{"name":296,"role":34,"phone":36,"phoneExt":36,"email":297},"Tracy Hagerty, MD","tracy.hagerty@uvmhealth.org",{"facility":299,"status":45,"city":300,"state":301,"zip":302,"country":49,"countryCode":50,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"University of Virginia","Charlottesville","Virginia","22903",{"type":52,"coordinates":304},[305,306],-78.47668,38.02931,{"lat":306,"lon":305},[309],{"name":310,"role":34,"phone":36,"phoneExt":36,"email":311},"Antonio Abbate, MD","antonio.abbate@virginia.edu",{"facility":313,"status":45,"city":314,"state":301,"zip":315,"country":49,"countryCode":50,"cosmosGeoPoint":316,"geoPoint":320,"contacts":321},"Virginia Commonwealth University","Richmond","23219",{"type":52,"coordinates":317},[318,319],-77.46026,37.55376,{"lat":319,"lon":318},[322],{"name":323,"role":34,"phone":36,"phoneExt":36,"email":324},"Georgia Thomas, MD","georgia.thomas@vcuhealth.org",{"facility":326,"status":45,"city":327,"state":36,"zip":36,"country":328,"countryCode":329,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"Jewish General Hospital","Montreal","Canada","CA",{"type":52,"coordinates":331},[332,333],-73.58781,45.50884,{"lat":333,"lon":332},[336],{"name":337,"role":34,"phone":36,"phoneExt":36,"email":338},"Vartan Mardigyan, MD","vartan.mardigyan@mail.mcgill.ca",{"facility":340,"status":45,"city":341,"state":36,"zip":36,"country":342,"countryCode":343,"cosmosGeoPoint":344,"geoPoint":348,"contacts":349},"Hippokration General Hospital","Athens","Greece","GR",{"type":52,"coordinates":345},[346,347],23.72784,37.98376,{"lat":347,"lon":346},[350],{"name":351,"role":34,"phone":36,"phoneExt":36,"email":352},"George Lazaros, MD","glaz35@hotmail.com",{"facility":354,"status":77,"city":355,"state":36,"zip":36,"country":356,"countryCode":357,"cosmosGeoPoint":358,"geoPoint":362,"contacts":363},"Fatebenefratelli Hospital Milano","Milan","Italy","IT",{"type":52,"coordinates":359},[360,361],12.59836,42.78235,{"lat":361,"lon":360},[364],{"name":365,"role":34,"phone":36,"phoneExt":36,"email":366},"Antonio Brucato, MD","antonio.brucato@unimi.it",{"facility":368,"status":77,"city":369,"state":36,"zip":36,"country":356,"countryCode":357,"cosmosGeoPoint":370,"geoPoint":374,"contacts":375},"University of Padua","Padua",{"type":52,"coordinates":371},[372,373],11.88586,45.40797,{"lat":373,"lon":372},[376],{"name":377,"role":34,"phone":36,"phoneExt":36,"email":378},"Alida Caforio, MD","alida.caforio@unipd.it",{"facility":380,"status":77,"city":381,"state":36,"zip":36,"country":356,"countryCode":357,"cosmosGeoPoint":382,"geoPoint":386,"contacts":387},"University Hospital","Torino",{"type":52,"coordinates":383},[384,385],11.99138,44.88856,{"lat":385,"lon":384},[388],{"name":389,"role":34,"phone":36,"phoneExt":36,"email":390},"Alessandro Andreis, MD","alessandro.andreis@unito.it",{"facility":392,"status":77,"city":393,"state":36,"zip":36,"country":356,"countryCode":357,"cosmosGeoPoint":394,"geoPoint":398,"contacts":399},"University Hospital Udine","Udine",{"type":52,"coordinates":395},[396,397],13.23715,46.0693,{"lat":397,"lon":396},[400],{"name":401,"role":34,"phone":36,"phoneExt":36,"email":402},"Valentino Collini, MD","valentino.collini@asufc.sanita.fvg.it",{"type":404,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100570519","phase-3-cardiolrx-in-recurrent-pericarditis-maveric-phase-3-100570519",false,"NCT06708299","CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)","CardiolRxTM in Recurrent Pericarditis (MAVERIC Phase 3) A Randomized, Double-blind, Placebo-controlled Trial","MAVERIC","Inclusion Criteria:\n\n1. Patients 18 years of age or older\n2. A history of recurrent pericarditis with stable disease and currently being treated with an IL-1 blocker, scheduled to be discontinued. Stable disease is defined as:\n\n   * treatment with an IL-1 blocker for at least 12 months,\n   * free of pericarditis recurrence for at least 6 months and this recurrence, if present, must have occurred in the setting of an interruption or tapering of an IL-1 blocker; and\n   * treatment with an unchanged dose and regimen of on an IL-1 blocker for at least 3 months prior to randomization.\n3. Pericarditis pain les or equal than 2 on the 11-point Numerical Rating Scale (NRS) for at least 7 days prior to randomization (Visit 1, Day 1)\n4. C-Reactive Protein (CRP) \\\u003C 1.0 mg\u002FdL during screening within 7 days prior to randomization (Visit 1, Day 1).\n5. Patients who have had a vasectomy or who are willing to use double barrier contraception methods with partners of childbearing potential during the conduct of the trial and for 2 months after the last dose of trial therapy.\n6. Patients of childbearing potential willing to use an acceptable method of contraception starting with trial therapy administration and for a minimum of 2 months after trial completion. Otherwise, these patients must be postmenopausal (at least 1 year absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone \\[FSH\\] ≥ 40 mIU\u002FmL \\[or ≥ 40 IU\u002FL\\] if less than 2 years postmenopausal) or be surgically sterile.\n\nAcceptable birth control methods that result in a failure rate of less than 1 % include oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); using double-barrier contraception methods with their partners; bilateral tubal occlusion; vasectomised partner; sexual abstinence.\n\nExclusion Criteria:\n\n1. Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker\n2. 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); systemic autoimmune disease (e.g., systemic lupus erythematosus)\n3. Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted)\n4. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin during screening within 7 days prior to randomization (Visit 1, Day 1)\n5. 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 during screening within 7 days prior to randomization (Visit 1, Day 1).\n6. Sepsis, defined as documented bacteremia during screening within 7 days prior to randomization (Visit 1, Day 1) or other untreated or uncontrolled bacterial infection\\*\n7. Prior history of sustained ventricular arrhythmia(s)\n8. History of diagnosed long QT syndrome\n9. QTc interval \\> 480 msec (biologically female) or \\> 470 msec (biologically male) (please refer to Section 9.2.3 for bundle branch block, bifascicular block and paced rhythm correction) or second or third degree atrioventricular (AV) block in a patient without an implanted functioning pacemaker device during screening within 7 days prior to randomization (Visit 1, Day 1)\n10. Showing suicidal tendency during the last 12 months, as defined by answering \"yes\" to question 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS), administered during screening within 7 days prior to randomization (Visit 1, Day 1)\n11. Participation in a clinical trial in which an investigational drug or device was administered within 30 days of screening or within 5 half-lives of the previous study drug, whichever is longer\n12. Inability or unwillingness to give informed consent\n13. Ongoing drug or alcohol abuse in the opinion of the investigator\n14. On any cannabinoid during the past month or unwilling to stay abstinent from all cannabis products for the duration of the trial\n15. Pregnant or breastfeeding\n16. Current diagnosis of active cancer, with the exception of non-melanoma skin cancer\n17. Any factor, which would make it unlikely that the patient can comply with the trial procedures\n18. Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment\n19. Has received systemic immunomodulatory agents as below prior to randomization:\n\n    1. Methotrexate (within 2 weeks)\n    2. Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks)\n    3. Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks)\n    4. Intravenous immune globulin (IVIG) (within 8 weeks)\n    5. Corticosteroids (within 4 weeks)\n20. Known hypersensitivity to the active substance or any of the excipients of the trial","ALL","18 Years",{"count":416,"type":417},110,"ESTIMATED","INTERVENTIONAL",[420],"PHASE3","Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation.\n\nDouble-blind treatment will be initiated 10 - 16 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks.\n\nThe objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.",[423],"Recurrent Pericarditis",[425,426],"IL-1 blocker-dependent recurrent pericarditis","pharmaceutically cannabidial","2026-06-02",{"date":429,"type":430},"2026-06-03","ACTUAL",{"date":432,"type":430},"2025-04-07",{"date":434,"type":417},"2026-10-21",{"name":5,"class":6},27]