Impact of CardiolRx on Myocardial Recovery in patients with Acute Myocarditis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cardiol Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

30 Mar 2023 → 4 Feb 2025

Decision date (initial)

2024-07-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Cardiol Therapeutics Inc.

External identifiers

EU CT number

2024-514639-10-00

EudraCT number

2021-006637-19

ClinicalTrials.gov

NCT05180240

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Efficacy: To evaluate the effect of CardiolRx on myocardial recovery for patients presenting with acute myocarditis.
Safety: To demonstrate that administration of CardiolRxTM in the proposed doses in this patient population is safe

Conditions and MedDRA coding

Acute Myocarditis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. Males and females 18 years of age or older
2. 2. Diagnosed with acute myocarditis including: a). Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin PLUS b). CMR diagnosis: (Lake Louise Criteria, Appendix 17.4 of this protocol) within 10 days prior to randomization OR c). Endomyocardial biopsy showing either cellular inflammation and/or immunohistochemistry consistent with inflammation
3. 3. Male subjects 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.
4. 4. 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 year absence of vaginal bleeding or spotting and confirmed by FSH ≥40 mIU/mL [or ≥ 40 IU/L] if less than 2 y postmenopausal) or be surgically sterile. The following reliable methods of contraception are: parenteral contraceptives, oral contraceptives, patch contraceptives, implantable hormonal contraceptives, intrauterine device or system, surgical sterilization (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexual abstinence, if this is the subject’s current practice. Periodic abstinence, i.e., calendar, symptothermal, or post-ovulation methods are not an acceptable form of contraception for this study. These methods of contraception also apply to female partners of male subjects.

Exclusion criteria 26

1. 1. Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery
2. 2. Severe valvular heart disease
3. 3. Inability to safely undergo CMR including administration of gadolinium
4. 4. Estimated glomerular filtration rate (eGFR) < 30 ml/min
5. 5. 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.
6. 6. Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection.
7. 7. Severe left ventricular (LV) dysfunction - requiring inotropic support, left ventricular assist device (LVAD) or other circulatory assist devices, or urgent need for transplantation
8. 8. Documented biopsy evidence of giant cell or eosinophilic myocarditis
9. 9. Prior history of sustained ventricular arrhythmia
10. 10. Acute coronary syndrome within 30 days
11. 11. Percutaneous coronary intervention within 30 days
12. 12. History of QT interval prolongation or QTc interval > 500 msec
13. 13. Treated with strong inducers CYP3A4 or CYP2C19, as listed in [Protocol] Appendix 17.8
14. 14. Treated with digoxin and/or type 1 or 3 antiarrhythmics
15. 15. Current participation in any research study involving investigational drugs or devices
16. 16. Inability or unwillingness to give informed consent
17. 17. Ongoing drug or alcohol abuse
18. 18. Women who are pregnant or breastfeeding
19. 19. Current diagnosis of cancer, with the exception of non-melanoma skin cancer
20. 20. Any factor, which would make it unlikely that the patient can comply with the study procedures
21. 21. On any cannabinoid during the past month
22. 22. Body weight > 170 kg
23. 23. Showing suicidal tendency as per the C-SSRS, administered at screening
24. 24. Hypersensitivity to any component of CardiolRxTM (Cannabidiol Oil)
25. 25. Patients under legal protection (protection of the court, or in curatorship or guardianship)
26. 26. Current seizures or history of seizures

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome of this study is comprised of two primary endpoints; the difference in the means of each: extra cellular volume (ECV) and of global longitudinal strain (GLS), as measured by cardiac magnetic resonance (CMR) at 12 weeks post randomization between the active and the placebo groups.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cardiol Therapeutics Inc.

Sponsor organisation

Cardiol Therapeutics Inc.

Address

2265 Upper Middle Road East Suite 602

City

Oakville

Postcode

L6H 0G5

Country

Canada

Scientific contact point

Organisation

Cardiol Therapeutics Inc.

Contact name

corporate inquiries

Public contact point

Organisation

Cardiol Therapeutics Inc.

Contact name

corporate inquiries

Third parties 11

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications