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Cannabidiol

CardiolRx for Myocarditis (ARCHER Trial)

Q: Is this research project currently looking for new participants?

The listed clinical trial on clinicaltrials.gov is currently looking for enrollees. This particular study was first announced on 6/22/2022 and the most recent update was 8/22/2022.

Q: Does this research require participants to be under 80 years old?

Patients that meet the age requirement of 18 to 75 years old are eligible for this clinical trial. If a patient is too young or too old, there are 16 other studies for patients under 18 and 76 respectively.

Q: How can I sign up to be a part of this research?

This upcoming clinical trial is testing a new myocarditis treatment and they are looking for 100 participants that meet the following criteria: being between 18-75 years old and currently suffering from myocarditis.

Q: What is the CardiolRx drug's current standing with the FDA?

CardiolRx falls into the Phase 2 category, which suggests that while there is some evidence of safety, none exists yet for efficacy. Our team scores it as a 2.

Q: In how many different hospitals is this trial taking place?

There are a total of 17 sites where this study is taking place, which includes the Minneapolis Heart Institute Foundation, MedStar Heart and Vascular Institute, Palm Springs Community Health Centre, and 14 other locations.

Q: Is the CardiolRx drug new to clinical trials?

CardiolRx was first studied in 2012 at Davidof <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center, Beilinson hospital, Rabin medical center. As of now, there have been a total of 120 completed studies. 83 clinical trials are still recruiting patients, with many of these based out of Minneapolis, <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a>.

Q: What is the primary aim of this clinical trial?

According to the study sponsor's report, the primary outcome being measured over the 12 weeks post randomization period is Global longitudinal Strain (GLS). Additionally, this trial will assess secondary outcomes related to changes in inflammatory and biomarker IL-10 (ng/ml), <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> Heart Association classification (NYHA), as well as changes in other inflammatory and biomarkers NT-proBNP (pg/ml), TNF-alpha (pg/ml), IL-1 beta (pg/ml) and IL-6 (pg/ml).

Phase 2

Recruiting

Research Sponsored by Cardiol Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with acute myocarditis including clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness) preferably followed by elevated troponin PLUS CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR Endomyocardial biopsy (EMB) showing either cellular inflammation and/or immunohistochemistry consistent with inflammation

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks post randomization

Awards & highlights

ARCHER Trial Summary

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

Who is the study for?

Adults diagnosed with acute myocarditis, confirmed by clinical symptoms and CMR or biopsy, can join this trial. Participants must agree to use contraception if necessary. Excluded are those with severe heart issues, recent heart procedures, drug/alcohol abuse, pregnant/breastfeeding women, certain other medical conditions or treatments.Check my eligibility

What is being tested?

The trial is testing CardiolRx (a THC-free Cannabidiol) against a placebo in patients with myocarditis over a period of 12 weeks. It's double-blind and randomized: neither doctors nor patients know who gets the real medicine. They'll check heart health using scans and various tests.See study design

What are the potential side effects?

While specific side effects for CardiolRx aren't listed here, typical cannabidiol side effects may include tiredness, diarrhea, changes in appetite/weight. Since it's free of THC (<5 ppm), psychoactive effects are not expected.

ARCHER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with acute myocarditis, confirmed by specific heart tests or biopsy.

Select...

I am a man who will use double barrier contraception or have had a vasectomy.

ARCHER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Global longitudinal Strain (GLS)

extracellular volume (ECV)

Secondary outcome measures

Left-ventricular ejection fraction (LVEF)

Other outcome measures

Change in CMR parameters (%)

Change in CMR parameters (g/m2)

Change in CMR parameters (mL/m2)

+10 more

Side effects data

From 2015 Phase 3 trial • 120 Patients • NCT02091375

31%

Diarrhoea

31%

Somnolence

26%

Decreased appetite

18%

Fatigue

15%

Vomiting

15%

Pyrexia

11%

Upper respiratory tract infection

11%

Lethargy

Convulsion

Weight decreased

Gamma-glutamyltransferase increased

Irritability

Cough

Transaminases increased

Status epilepticus

Nasopharyngitis

Pneumonia

Oral herpes

Platelet count

Abdominal distension

Abdominal pain

Gastrointestinal haemorrhage

Asthenia

Lower respiratory tract infection

Gamma-glutamyltransferase

Hypophagia

Hypotonia

Myoclonus

Respiratory failure

Epistaxis

Hypovolaemic shock

Aspartate aminotransferase increased

Liver function test abnormal

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

GWP42003-P 20 mg/kg/Day Dose

ARCHER Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CardiolRxExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

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

788 Total Patients Enrolled

Media Library

CardiolRx (Cannabidiol) Clinical Trial Eligibility Overview. Trial Name: NCT05180240 — Phase 2

Myocarditis Research Study Groups: CardiolRx, Placebo

Myocarditis Clinical Trial 2023: CardiolRx Highlights & Side Effects. Trial Name: NCT05180240 — Phase 2

CardiolRx (Cannabidiol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05180240 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project currently looking for new participants?

"The listed clinical trial on clinicaltrials.gov is currently looking for enrollees. This particular study was first announced on 6/22/2022 and the most recent update was 8/22/2022."

Answered by AI

Does this research require participants to be under 80 years old?

"Patients that meet the age requirement of 18 to 75 years old are eligible for this clinical trial. If a patient is too young or too old, there are 16 other studies for patients under 18 and 76 respectively."

Answered by AI

How can I sign up to be a part of this research?

"This upcoming clinical trial is testing a new myocarditis treatment and they are looking for 100 participants that meet the following criteria: being between 18-75 years old and currently suffering from myocarditis."

Answered by AI

What is the CardiolRx drug's current standing with the FDA?

"CardiolRx falls into the Phase 2 category, which suggests that while there is some evidence of safety, none exists yet for efficacy. Our team scores it as a 2."

Answered by AI

In how many different hospitals is this trial taking place?

"There are a total of 17 sites where this study is taking place, which includes the Minneapolis Heart Institute Foundation, MedStar Heart and Vascular Institute, Palm Springs Community Health Centre, and 14 other locations."

Answered by AI

Is the CardiolRx drug new to clinical trials?

"CardiolRx was first studied in 2012 at Davidof Cancer Center, Beilinson hospital, Rabin medical center. As of now, there have been a total of 120 completed studies. 83 clinical trials are still recruiting patients, with many of these based out of Minneapolis, Minnesota."

Answered by AI

What is the primary aim of this clinical trial?

"According to the study sponsor's report, the primary outcome being measured over the 12 weeks post randomization period is Global longitudinal Strain (GLS). Additionally, this trial will assess secondary outcomes related to changes in inflammatory and biomarker IL-10 (ng/ml), New york Heart Association classification (NYHA), as well as changes in other inflammatory and biomarkers NT-proBNP (pg/ml), TNF-alpha (pg/ml), IL-1 beta (pg/ml) and IL-6 (pg/ml)."

Answered by AI