Recurrent Pericarditis
Conditions
Brief summary
The primary efficacy endpoint is the proportion of patients free from a new episode of recurrent pericarditis*, from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24)., * For the purpose of this trial, pericarditis recurrence is defined as the recurrence of typical pericarditis pain associated with supportive objective evidence of pericarditis (at least 1 day with pericarditis pain measurement ≥ 4 on the 11-point NRS AND a CRP value ≥ 1 mg/dL either on the same day or separated by no more than 7 days., Safety parameters include the number of AEs and SAEs, changes in C-SSRS and in laboratory parameters, including liver function parameters and INR, as well as ECG intervals and rhythm during the trial period. In addition, all patients will have Pharmocokinetic (PK) samples obtained according to the Schedule of Trial Procedures (see Section 20.2).
Detailed description
Exploratory efficacy endpoints include: - the restricted mean time to a new episode of pericarditis recurrence from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24) - the mean pain score using an 11-point NRS at Visit 6 (Week 8) and at Visit 9 (Week 24) (highest pain score recorded during the 7 days prior to Visit 6 and Visit 9) - the change in CRP from Visit 1 (Day 1) to Visit 6 (Week 8) and Visit 9 (Week 24), as measured by the central laboratory., The secondary efficacy endpoint is the percentage of days with no or minimal pericarditis pain as assessed by an NRS score ≤ 2 from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24).
Interventions
DRUGCardiolRx™ Placebo is a non-aqueous solution of medium chain triglycerides with 1.0% vitamin E as anti-oxidant. CardiolRx™ Placebo is a pale yellow clear liquid. The CardiolRx™ Placebo product is essentially the same as the CardiolRx™ drug product with the exception that the placebo does not include the active drug substance
DRUGcannabidiol.
DRUGCardiolRx
Sponsors
Cardiol Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the proportion of patients free from a new episode of recurrent pericarditis*, from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24)., * For the purpose of this trial, pericarditis recurrence is defined as the recurrence of typical pericarditis pain associated with supportive objective evidence of pericarditis (at least 1 day with pericarditis pain measurement ≥ 4 on the 11-point NRS AND a CRP value ≥ 1 mg/dL either on the same day or separated by no more than 7 days., Safety parameters include the number of AEs and SAEs, changes in C-SSRS and in laboratory parameters, including liver function parameters and INR, as well as ECG intervals and rhythm during the trial period. In addition, all patients will have Pharmocokinetic (PK) samples obtained according to the Schedule of Trial Procedures (see Section 20.2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory efficacy endpoints include: - the restricted mean time to a new episode of pericarditis recurrence from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24) - the mean pain score using an 11-point NRS at Visit 6 (Week 8) and at Visit 9 (Week 24) (highest pain score recorded during the 7 days prior to Visit 6 and Visit 9) - the change in CRP from Visit 1 (Day 1) to Visit 6 (Week 8) and Visit 9 (Week 24), as measured by the central laboratory., The secondary efficacy endpoint is the percentage of days with no or minimal pericarditis pain as assessed by an NRS score ≤ 2 from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24). | — |
Countries
Greece, Italy
Outcome results
None listed