Trial Outcomes & Findings for Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis (NCT NCT05180240)
NCT ID: NCT05180240
Last Updated: 2026-06-17
Results Overview
Change of ECV from baseline at 12 weeks, measured by cardiac Cardiac MRI. ECV is measuring the degree of edema and fibrosis. The unit of measure was percentage. It was the percentage of myocardial tissue that is extracellular space (i.e. fraction of the myocardium occupied by extracellular matrix and interstitial fluid).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
12 weeks post randomization
Results posted on
2026-06-17
Participant Flow
166 patients signed informed consent between July 28, 2022, and October 31,2024, in 29 centers in Brazil; France; Israel and the United States. There were 57 screening failures and 109 patients were randomized to either CardiolRx™ (N=56) or Placebo (N=53). All randomized patients started the IMP and completed the study as planned - no patient withdrew prematurely from follow-up. In total, 11 patients discontinued the IMP before the Week 12 visit, 6 on CardiolRx and 5 on placebo.
Participant milestones
| Measure |
CardiolRx
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
Placebo
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
53
|
|
Overall Study
COMPLETED
|
56
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not all patients had CMRs analyzable with respect to GLS. For this reason, the patients numbers differ for all of then endpoint results.
Baseline characteristics by cohort
| Measure |
CardiolRx
n=49 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
Placebo
n=50 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=49 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 15.35 • n=49 Participants
|
39.6 years
STANDARD_DEVIATION 15.47 • n=50 Participants
|
37.7 years
STANDARD_DEVIATION 15.45 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=49 Participants
|
9 Participants
n=50 Participants
|
19 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=49 Participants
|
41 Participants
n=50 Participants
|
80 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=49 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=49 Participants
|
2 Participants
n=50 Participants
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=49 Participants
|
41 Participants
n=50 Participants
|
79 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=49 Participants
|
5 Participants
n=50 Participants
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=49 Participants
|
4 participants
n=50 Participants
|
8 participants
n=99 Participants
|
|
Region of Enrollment
Brazil
|
22 participants
n=49 Participants
|
28 participants
n=50 Participants
|
50 participants
n=99 Participants
|
|
Region of Enrollment
Israel
|
7 participants
n=49 Participants
|
7 participants
n=50 Participants
|
14 participants
n=99 Participants
|
|
Region of Enrollment
France
|
16 participants
n=49 Participants
|
11 participants
n=50 Participants
|
27 participants
n=99 Participants
|
|
Global longitudinal strain (GLS)
|
-15.35 %
STANDARD_DEVIATION 3.10 • n=49 Participants • Not all patients had CMRs analyzable with respect to GLS. For this reason, the patients numbers differ for all of then endpoint results.
|
-15.34 %
STANDARD_DEVIATION 4.06 • n=49 Participants • Not all patients had CMRs analyzable with respect to GLS. For this reason, the patients numbers differ for all of then endpoint results.
|
-15.35 %
STANDARD_DEVIATION 3.60 • n=98 Participants • Not all patients had CMRs analyzable with respect to GLS. For this reason, the patients numbers differ for all of then endpoint results.
|
|
Extracellular volume (ECV)
|
29.74 %
STANDARD_DEVIATION 4.47 • n=41 Participants • Not all patients had analyzable baseline CMRs with respect to ECV.
|
30.83 %
STANDARD_DEVIATION 4.31 • n=42 Participants • Not all patients had analyzable baseline CMRs with respect to ECV.
|
30.29 %
STANDARD_DEVIATION 4.40 • n=83 Participants • Not all patients had analyzable baseline CMRs with respect to ECV.
|
|
Left-ventricular ejection fraction (LVEF)
|
61.90 %
STANDARD_DEVIATION 8.88 • n=49 Participants
|
59.35 %
STANDARD_DEVIATION 10.79 • n=50 Participants
|
60.61 %
STANDARD_DEVIATION 9.93 • n=99 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post randomizationPopulation: modified ITT population of all patients who had analyzable baseline and week 12 CMR tests with respect to ECV. Only for 71 patients were the difference in ECV measurable by cardiac CMR. Therefore, the values are not available for all patients of the mITT analysis population.
Change of ECV from baseline at 12 weeks, measured by cardiac Cardiac MRI. ECV is measuring the degree of edema and fibrosis. The unit of measure was percentage. It was the percentage of myocardial tissue that is extracellular space (i.e. fraction of the myocardium occupied by extracellular matrix and interstitial fluid).
Outcome measures
| Measure |
CardiolRx
n=33 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
Placebo
n=38 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
|---|---|---|
|
Extracellular Volume (ECV)
|
-1.88 percentage of tissue volume outside cell
Standard Deviation 3.25
|
-1.60 percentage of tissue volume outside cell
Standard Deviation 4.57
|
PRIMARY outcome
Timeframe: 12 weeks post randomizationPopulation: modified ITT population of all patients who had analyzable baseline and week 12 CMR tests with respect to GLS. Only for 108 patients were the difference in GLS measurable by cardiac CMR. Therefore, the values are not available for all patients of the mITT analysis population.
The outcome was the change in GLS from baseline at 12 weeks, measured by cardiac Cardiac MRI. GLS is a predictor of cardiac function. The unit of measure is percentage. It is the percent change in myocardial length relative to its original (end-diastolic) length along the long axis. Longitudinal strain during systole is usually negative, because the ventricle shortens; normal peak GLS in healthy adults is around -20% (i.e., 20% shortening relative to original length)
Outcome measures
| Measure |
CardiolRx
n=49 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
Placebo
n=49 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
|---|---|---|
|
Global Longitudinal Strain (GLS)
|
-0.68 % of change in ventricle length
Standard Deviation 3.6
|
-0.62 % of change in ventricle length
Standard Deviation 3.68
|
SECONDARY outcome
Timeframe: 12 weeks post randomizationPopulation: modified ITT population
Left-ventricular ejection fraction (LVEF) as measured by Cardiac MRI at 12 weeks. LVEF is a measure of cardiac function. The unit of measure is percentage. It is the percent of end-diastolic blood volume in the left ventricle that is ejected with each systolic contraction. Mathematically, LVEF = (stroke volume/end-diastolic volume) x 100.
Outcome measures
| Measure |
CardiolRx
n=49 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
Placebo
n=50 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
|---|---|---|
|
Change in Left-ventricular Ejection Fraction (LVEF) From Baseline at 12 Weeks
|
0.65 percentage
Standard Deviation 8.38
|
1.75 percentage
Standard Deviation 9.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 12 weeks of treatmentPopulation: modified ITT
Left-ventricular mass at week 12, measured with cardiac MRI. Unit of measure is grams (g) of myocardium. The mass of left-ventricular myocardial tissue was calculated from lCMR using geometric assumptions (e.g., Devereux/ASE cube formula) and myocardial density.
Outcome measures
| Measure |
CardiolRx
n=49 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
Placebo
n=50 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
|---|---|---|
|
Change in Left-ventricular Mass From Baseline at 12 Weeks
|
-11.11 gram
Standard Deviation 15.32
|
-2.83 gram
Standard Deviation 23.39
|
POST_HOC outcome
Timeframe: baseline to 12 weeksPopulation: modified ITT population of all patients who had analyzable baseline and week 12 CMR tests with respect to ECV. Only for 71 patients were the difference in ECV measurable by cardiac CMR. Therefore, the values are not available for all patients of the mITT analysis population.
The total Extracellular Volume (ECV) was calculated in mL using the following formula:Total ECV volume (mL) = ܸECV fraction (%) x LV mass (g)/ 1.05 where 1.05 = the specificgravity of myocardium in g/mL. It is the absolute extracellular volume of the tissue or body compartment, reported as physical volume instead of fraction or percent.
Outcome measures
| Measure |
CardiolRx
n=33 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
Placebo
n=38 Participants
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
* Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
CardiolRx: Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
|
|---|---|---|
|
Change in Extracellular Volume (ECV) in ml From Baseline at 12 Weeks
|
-5.96 mL
Standard Deviation 7.35
|
-2.73 mL
Standard Deviation 9.48
|
Adverse Events
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
Serious events: 6 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
n=56 participants at risk
CardiolRx
Cannabidiol, pharmaceutically produced with \< 5 ppm THC: CardiolRx 2.5 mg/kg to 10 mg/kg of body weight b.i.d taken orally with food
|
Placebo
n=53 participants at risk
Placebo
Placebo: Placebo 2.5 mg/kg to 10 mg/kg of body weight b.i.d taken orally with food
|
|---|---|---|
|
Cardiac disorders
Myocarditis
|
1.8%
1/56 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
0.00%
0/53 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Cardiac disorders
Palpitation
|
0.00%
0/56 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
1.9%
1/53 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.8%
1/56 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
0.00%
0/53 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/56 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
0.00%
0/53 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
General disorders
Chest pain
|
1.8%
1/56 • Number of events 2 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
0.00%
0/53 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/56 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
1.9%
1/53 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/56 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
1.9%
1/53 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Investigations
Transaminases increased
|
1.8%
1/56 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
0.00%
0/53 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/56 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
1.9%
1/53 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Nervous system disorders
Tremor
|
1.8%
1/56 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
0.00%
0/53 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
Other adverse events
| Measure |
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC
n=56 participants at risk
CardiolRx
Cannabidiol, pharmaceutically produced with \< 5 ppm THC: CardiolRx 2.5 mg/kg to 10 mg/kg of body weight b.i.d taken orally with food
|
Placebo
n=53 participants at risk
Placebo
Placebo: Placebo 2.5 mg/kg to 10 mg/kg of body weight b.i.d taken orally with food
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
1.8%
1/56 • Number of events 2 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
7.5%
4/53 • Number of events 4 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Gastrointestinal disorders
Diarrhea
|
32.1%
18/56 • Number of events 20 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
20.8%
11/53 • Number of events 11 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Gastrointestinal disorders
Nausea
|
8.9%
5/56 • Number of events 5 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
3.8%
2/53 • Number of events 2 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
General disorders
Asthenia
|
1.8%
1/56 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
13.2%
7/53 • Number of events 7 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
General disorders
Chest pain
|
16.1%
9/56 • Number of events 11 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
7.5%
4/53 • Number of events 5 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/56 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
5.7%
3/53 • Number of events 3 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Investigations
Alanine aminotransferase increased
|
8.9%
5/56 • Number of events 5 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
5.7%
3/53 • Number of events 4 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
3/56 • Number of events 4 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
1.9%
1/53 • Number of events 1 • 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US)
|
Additional Information
Senior Director Clinical Operations
Cardiol Therapeutics Inc.
Phone: +1 289 9100862
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place