Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)
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ClinicalTrials.gov Identifier: NCT05494788 |
Recruitment Status :
Active, not recruiting
First Posted : August 10, 2022
Last Update Posted : April 9, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | August 8, 2022 | ||||
First Posted Date ICMJE | August 10, 2022 | ||||
Last Update Posted Date | April 9, 2024 | ||||
Actual Study Start Date ICMJE | November 30, 2022 | ||||
Estimated Primary Completion Date | June 15, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
11-point NRS pain score [ Time Frame: 8 weeks ] change in patient-reported pericarditis pain using an 11-point NRS from baseline to 8 weeks
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot) | ||||
Official Title ICMJE | Impact of CardiolRxTM on Recurrent Pericarditis An Open Label Pilot Study (MAvERIC-Pilot Study) | ||||
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:
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Open label Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Recurrent Pericarditis | ||||
Intervention ICMJE | Drug: CardiolRx
Pharmaceutically produced Cannabidiol
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Study Arms ICMJE | Experimental: CardiolRx
pharmaceutically produced Cannabidiol
Intervention: Drug: CardiolRx
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
25 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 15, 2024 | ||||
Estimated Primary Completion Date | June 15, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
At least two of:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05494788 | ||||
Other Study ID Numbers ICMJE | Cardiol 100-004 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Cardiol Therapeutics Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Cardiol Therapeutics Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Cardiol Therapeutics Inc. | ||||
Verification Date | February 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |