Evaluating CRD-4730 for treating Catecholaminergic Polymorphic Ventricular Tachycardia
A Phase 2A, Investigator & Subject Blinded, Sponsor Unblinded, Placebo-Controlled, Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of CRD-4730 in Participants with Catecholaminergic Polymorphic Ventricular Tachycardia
This study is testing a new drug called CRD-4730 to see if it can help adults with Catecholaminergic Polymorphic Ventricular Tachycardia manage their symptoms better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Cardurion Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 11 sites (Cincinnati, Ohio and 10 other locations) |
| Trial ID | NCT06005428 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial investigates the safety, tolerability, pharmacokinetics, and pharmacodynamics of CRD-4730 in adults diagnosed with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). Participants will be randomly assigned to receive two different doses of CRD-4730 and a placebo in a double-blind manner. The study aims to assess the drug's effectiveness in managing symptoms associated with CPVT through a multicenter approach. Each participant will undergo a series of evaluations to monitor their response to the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of CPVT based on genetic screening.
Not a fit: Patients with clinically significant structural heart disease or recent history of myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of CPVT, reducing the risk of life-threatening arrhythmias.
How similar studies have performed: While there have been studies on CPVT treatments, the specific approach using CRD-4730 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males or Females ≥18 years of age, at screening. 2. Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening. 3. The participant can perform an EST during which frequent premature ventricular contraction (PVCs) (≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the investigator. 4. Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to screening. 5. Adhere to all contraceptive criteria. Exclusion Criteria: 1. Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease. 2. History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening. 3. History of malignancy within the past 5 years at screening (except successfully treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ). 4. Female participant that is pregnant or lactating/ breastfeeding, or has plans to do so during the study or within 3 months following last dose of study drug. 5. Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.
Where this trial is running
Cincinnati, Ohio and 10 other locations
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic Children's Hospital — Cleveland, Ohio, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- Stollery Children's Hospital University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- University of British Columbia (UBC) Hospital — Vancouver, British Columbia, Canada (Recruiting)
- British Columbia Children's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- University of Western Ontario — London, Ontario, Canada (Recruiting)
- Hôptal Nord Laennec — Nantes, Loire-Atlantique, France (Recruiting)
- Hôpital Louis Pradel — Bron, France (Recruiting)
- Groupe Hospitalier Bichat Claude Bernard — Paris, France (Recruiting)
- IRCCS Pavia Istituti Clinici Scientifici Maugeri Spa Società Benefit — Pavia, Lombardia, Italy (Recruiting)
Study contacts
- Study coordinator: Jason Homsy, M.D., Ph.D.
- Email: infoCPVT@cardurion.com
- Phone: (617) 863-8088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.