(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]
REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients
Status: Recruiting
Location: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Houston Methodist Hospital, Johns Hopkins University, Legacy Hospital and Health Center DBA Legacy Research Institute, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, TKL Research Inc., University of California - San Diego, University of Nebraska Medical Center, University of Vermont Medical Center, Virginia Commonwealth University
Conditions: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Houston Methodist Hospital, Johns Hopkins University, Legacy Hospital and Health Center DBA Legacy Research Institute, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, TKL Research Inc., University of California - San Diego, University of Nebraska Medical Center, University of Vermont Medical Center, Virginia Commonwealth University
City/State:
Anchorage, Alaska
Tucson, Arizona
La Jolla, California
San Diego
Davenport, Iowa
Baltimore, Maryland
Boston, Massachusetts
Minneapolis, Minnesota
Rochester, Minnesota
Saint Louis, Missouri
Omaha, Nebraska
Fair Lawn, New Jersey
New York, New York
Cincinnati, Ohio
Cleveland, Ohio
Portland, Oregon
Pittsburgh, Pennsylvania
Houston, Texas
Burlington, Vermont
Richmond, Virginia
Seattle, Washington
Contact Information:
JoAnn Clair, PhD
781 431 9100
[email protected]
Brief Summary:
The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.
Impact of CardiolRxTM on Recurrent Pericarditis
Status: Recruiting
Location: Cleveland Clinic, Mayo Clinic in Rochester, MedStar Heart and Vascular Institute, Minneapolis Heart Institute Foundation, Pima Heart and Vascular, University of Vermont Medical Center, Virginia Commonwealth University
Conditions: Cleveland Clinic, Mayo Clinic in Rochester, MedStar Heart and Vascular Institute, Minneapolis Heart Institute Foundation, Pima Heart and Vascular, University of Vermont Medical Center, Virginia Commonwealth University
City/State:
Tucson, Arizona
Washington D.C.
Minneapolis, Minnesota
Rochester, Minnesota
Cleveland, Ohio
Burlington, Vermont
Richmond, Virginia
Contact Information:
Andrea B Parker, PhD
+1 289 910 0862
[email protected]
Andrew Hamer, MD
[email protected]
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.
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.