Trial Outcomes & Findings for Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot) (NCT NCT05494788)

NCT ID: NCT05494788

Last Updated: 2025-10-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2025-10-20

Participant Flow

First patient enrolled on January 9, 2023; Last patient last visit on September 6, 2024

8-week follow up; 18-week extension period

Participant milestones

Measure	CardiolRx pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol, titrated from 2.5/5 mg/kg of body weight to 10 mg/kg of body weight (or maximally tolerated dose), taken orally twice daily
Initial Treatment Period STARTED	27
Initial Treatment Period COMPLETED	24
Initial Treatment Period NOT COMPLETED	3
Extension Period STARTED	24
Extension Period COMPLETED	22
Extension Period NOT COMPLETED	2

Reasons for withdrawal

Measure	CardiolRx pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol, titrated from 2.5/5 mg/kg of body weight to 10 mg/kg of body weight (or maximally tolerated dose), taken orally twice daily
Initial Treatment Period Adverse Event	2
Initial Treatment Period Withdrawal by Subject	1
Extension Period Adverse Event	1
Extension Period Withdrawal by Subject	1

Baseline Characteristics

Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)

Baseline characteristics by cohort

Measure	CardiolRx n=27 Participants pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol
Age, Continuous	52.7 years STANDARD_DEVIATION 14.96 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants
NRS Scores (Outcome measure 1)	5.8 units on a scale STANDARD_DEVIATION 1.71 • n=5 Participants
CRP	4.44 mg/dl STANDARD_DEVIATION 7.21 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: All patients enrolled

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.

Outcome measures

Measure	CardiolRx n=27 Participants pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol
11-point NRS Pain Score	-3.7 units on a scale Standard Deviation 2.07

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 weeks

Percentage of patients with pericarditis recurrence during the extension period (EP)

Outcome measures

Measure	CardiolRx n=24 Participants pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol
Pericarditis Recurrence During the Extension Period (EP)	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

CRP change from baseline, as measured locally at baseline and at weeks 8, 16, and 26.

Outcome measures

Measure	CardiolRx n=22 Participants pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol
CRP Change From Baseline	0.07 mg/dl Standard Deviation 0.10

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Percentage of patients with normalized CRP levels at 26 weeks (for patients with CRP ≥ 1.0 mg/dL at baseline)

Outcome measures

Measure	CardiolRx n=7 Participants pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol
Percentage of Patients With Normalized CRP Levels	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Percentage of patients with normalized CRP levels at 8 weeks (for patients with CRP ≥1.0 mg/dL at baseline)

Outcome measures

Measure	CardiolRx n=12 Participants pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol
Percentage of Patients With Normalized CRP Levels	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Over 26 weeks

Time to CRP normalization for patients with CRP ≥1.0 mg/dL at baseline

Outcome measures

Measure	CardiolRx n=7 Participants pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol
Time to Normalized CRP Levels	26.4 days Standard Deviation 18.46

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Change in pain score from baseline using 11-point NRS after 26 weeks of treatment. Nominal Rating Scale from 0 to 10, where 0 represents no pain and 10 maximum pain.

Outcome measures

Measure	CardiolRx n=22 Participants pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol
11-point NRS Pain Score	4.3 units on a scale Standard Deviation 2.46

Adverse Events

CardiolRx

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	CardiolRx n=27 participants at risk pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol
General disorders Chest pain	3.7% 1/27 • Number of events 1 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Infections and infestations ENTERITIS INFECTIOUS	3.7% 1/27 • Number of events 1 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Injury, poisoning and procedural complications Tooth fracture	3.7% 1/27 • Number of events 1 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Skin and subcutaneous tissue disorders DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS	3.7% 1/27 • Number of events 1 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.

Other adverse events

Measure	CardiolRx n=27 participants at risk pharmaceutically produced Cannabidiol CardiolRx: Pharmaceutically produced Cannabidiol
Cardiac disorders Pericarditis	29.6% 8/27 • Number of events 10 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Gastrointestinal disorders Abdominal discomfort	14.8% 4/27 • Number of events 4 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
General disorders Chest discomfort	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Infections and infestations COVID-19	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURAL COMPLICATIONS	11.1% 3/27 • Number of events 3 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Investigations ALANINE AMINOTRANSFERASE INCREASED	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Musculoskeletal and connective tissue disorders Neck pain	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Nervous system disorders Headache	14.8% 4/27 • Number of events 4 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Skin and subcutaneous tissue disorders Rash	25.9% 7/27 • Number of events 7 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Gastrointestinal disorders Abdominal distension	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Gastrointestinal disorders Abdominal pain	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Gastrointestinal disorders Diarrhoea	51.9% 14/27 • Number of events 14 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Gastrointestinal disorders Nausea	18.5% 5/27 • Number of events 9 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
General disorders Chest pain	37.0% 10/27 • Number of events 13 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
General disorders Fatigue	18.5% 5/27 • Number of events 5 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
General disorders Pain	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
General disorders Peripheral swelling	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Infections and infestations Upper respiratory tract infection	18.5% 5/27 • Number of events 7 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.
Investigations CRP increased	7.4% 2/27 • Number of events 2 • Adverse events were collected from the signed ICF until the last study visit for each patient, up to 26 weeks. AE description does not differ from the clinical trials.gov AE definition. AEs were collected on an ongoing basis throughout the study.

Additional Information

Andrea B. Parker, MSc., PhD, Senior Director of Clinical Operations

Cardiol Therapeutics Inc.

Phone: +1 289 9100862

Email: andrea.parker@cardiolrx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place