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CardiolRx for Acute Myocarditis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acute MyocarditisCardiolRx - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new drug, CardiolRx, to see if it can help people with myocarditis.

Eligible Conditions
  • Acute Myocarditis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary ยท 15 Secondary ยท Reporting Duration: 12 weeks post randomization

12 weeks post randomization
Global longitudinal Strain (GLS)
Left-ventricular ejection fraction (LVEF)
Survival, free from major event
extracellular volume (ECV)
Week 12
24-hour Holter ECG monitoring abnormalities
Change in CMR parameters
Change in CMR parameters (%)
Change in CMR parameters (g/m2)
Change in CMR parameters (mL/m2)
Changes in inflammatory and biomarker IL-10 (ng/ml)
Changes in inflammatory and biomarker hs-troponin (nh/ml)
Changes in inflammatory and biomarkers NT-proBNP (pg/ml), TNF-alpha (pg/ml), IL-1 beta (pg/ml) and IL-6 (pg/ml)
Changes in inflammatory and biomarkers hs-CRP (mg/l), and ferritin (mg/l)
Kansas City Cardiomyopathy Questionnaire (KCCQ)
New York Heart Association classification (NYHA)
Normalization of prognostically important ECG changes
Percentage of patients recovered
Time to resolution of clinical symptoms

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Side Effects for

GWP42003-P 20 mg/kg/Day Dose
31%Diarrhoea
31%Somnolence
26%Decreased appetite
18%Fatigue
15%Vomiting
15%Pyrexia
11%Lethargy
11%Upper respiratory tract infection
8%Convulsion
7%Weight decreased
7%Gamma-glutamyltransferase increased
7%Irritability
7%Cough
7%Transaminases increased
5%Status epilepticus
5%Nasopharyngitis
2%Epistaxis
2%Asthenia
2%Gastrointestinal haemorrhage
2%Oral herpes
2%Hypotonia
2%Pneumonia
2%Abdominal pain
2%Hypovolaemic shock
2%Gamma-glutamyltransferase
2%Myoclonus
2%Respiratory failure
2%Abdominal distension
2%Lower respiratory tract infection
2%Platelet count
2%Hypophagia
2%Aspartate aminotransferase increased
2%Liver function test abnormal
2%Headache
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT02091375) in the GWP42003-P 20 mg/kg/Day Dose ARM group. Side effects include: Diarrhoea with 31%, Somnolence with 31%, Decreased appetite with 26%, Fatigue with 18%, Vomiting with 15%.

Trial Design

2 Treatment Groups

CardiolRx
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants ยท 2 Treatment Groups

Primary Treatment: CardiolRx ยท Has Placebo Group ยท Phase 2

CardiolRx
Drug
Experimental Group ยท 1 Intervention: CardiolRx ยท Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group ยท 1 Intervention: CardiolRx ยท Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks post randomization

Who is running the clinical trial?

Cardiol Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
115 Total Patients Enrolled
Dennis McNamara, MDStudy ChairUniversity of Pittsburgh
4 Previous Clinical Trials
1,063 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 ยท All Participants ยท 6 Total Inclusion Criteria

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References

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