Impact of CardiolRxTM on Recurrent Pericarditis An Open Label Pilot Study (MAvERIC-Pilot Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 8
- 主要终点
- 11-point NRS Pain Score
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
- •Women of childbearing potential willing to use an acceptable method of contraception starting with study drug administration and for a minimum of 2 months after study completion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone [FSH] ≥40 mIU/mL [or ≥ 40 IU/L] if less than 2 y postmenopausal) or be surgically sterile.
- •Diagnosis of pericarditis according to the 2015 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler et al. 2015):
- •At least two of:
- •Pericarditic chest pain
- •Pericardial rub
- •New widespread ST-segment elevation or PR-segment depression according to electrocardiogram (ECG) findings
- •Pericardial effusion (new or worsening)
- •Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP
排除标准
- •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
- •Inability or unwillingness to give informed consent
- •Ongoing drug or alcohol abuse
- •On any cannabinoid during the past month
- •Women who are pregnant or breastfeeding
- •Current diagnosis of cancer, with the exception of non-melanoma skin cancer
- •Any factor, which would make it unlikely that the patient can comply with the study procedures
- •Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS), administered at screening
- •On digoxin and/or type 1 or 3 antiarrhythmics
- •On immunosuppressive therapy with any of the following:
- •Canakinumab
- •Methotrexate
- •Azathioprine
- •Cyclosporine
- •Intravenous immune globulin (IVIG)
研究组 & 干预措施
CardiolRx
pharmaceutically produced Cannabidiol
干预措施: CardiolRx (Drug)
结局指标
主要结局
11-point NRS Pain Score
时间窗: 8 weeks
Change in pain score from baseline using 11-point NRS after 8 weeks of treatment. Nominal Rating Scale from 0 to 10, where 0 represents no pain and 10 maximum pain.
次要结局
未报告次要终点