CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled / 109 target
Drug / intervention
CardiolRxdrug
Likely dose
2.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05180240
NCT05180240Phase 2CompletedMonitor (2.3/mo)Completion was 16mo ago
CompareCT.gov

Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis. A Double-blind, Placebo-controlled Trial

Cardiol Therapeutics Inc.·interventional·Posted Jan 6, 2022·Updated Jun 17, 2026

In Brief

A Phase 2 clinical trial evaluating CardiolRx for Acute Myocarditis. Completed, enrolled 109 participants across 37 sites in 5 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo. CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC\<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests. The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myocarditis
CountriesBrazil, Canada, France, Israel, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJan 6, 2022
Enrollment StartJul 28, 2022
Primary CompletionJan 31, 2025
Study CompletionFeb 4, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.5 years ago

Arms & Interventions

CardiolRxexperimental

* 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

Drug: CardiolRx
Placeboplacebo_comparator

* 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

Drug: CardiolRx

Interventions

CardiolRxdrug

Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.