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Small Molecule Drug
ARM210 for Ventricular Tachycardia
Phase 2
Waitlist Available
Led By Michael J Ackerman, MD PhD
Research Sponsored by Armgo Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants have a confirmed genetic diagnosis of CPVT1 and supporting clinical phenotype, including residual ventricular ectopy on a stable standard-of-care, CPVT1-directed treatment regimen
Is a woman of non-childbearing potential
Must not have
Is mentally or legally incapacitated at the time of screening visit
Is unable to take orally administered tablets
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Summary
This trial tests a new drug, S48168 (ARM210), for people with a heart condition called CPVT1. The drug aims to fix faulty heart cell channels caused by genetic mutations, helping patients live normal lives without dangerous heart rhythms.
Who is the study for?
Adults aged 18-65 with a confirmed genetic diagnosis of CPVT1 and related symptoms, who can follow the study plan and are not pregnant or breastfeeding. They must have a BMI ≤ 36 kg/m2, no recent drug abuse, controlled diabetes if present, no significant heart issues in the past five years, and agree to avoid certain medications and blood donations before and during the trial.
What is being tested?
The trial is testing S48168 (ARM210), which aims to fix leaky calcium channels caused by CPVT1 mutations that lead to dangerous heart rhythms. Participants will either receive this new drug or a placebo without knowing which one they're getting to compare effectiveness.
What are the potential side effects?
While specific side effects for S48168 (ARM210) aren't listed here, common ones for new drugs targeting heart conditions may include dizziness, headache, nausea, potential allergic reactions or changes in blood pressure or heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have CPVT1 with symptoms, even on my current treatment.
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I cannot become pregnant.
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I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not mentally or legally able to make decisions at the time of screening.
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I cannot take pills by mouth.
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My diabetes is not under control, with an HbA1c over 7% or I have diabetic neuropathy.
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I can avoid drugs affecting CYP2C8 enzymes for 28 days before and during the study.
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I have had a heart attack in the last 5 years or have heart failure.
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I do not have significant heart issues apart from high blood pressure.
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My kidney function is reduced, with a creatinine clearance below 40 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The effect of S48168 (ARM210) treatment on the amount and complexity of exercise-• Change in ectopy score from baseline to Day 28 versus placebo (pre-dose Period 1 baseline to Day 28 Period 1 versus Day 28 Period 2
Secondary study objectives
Incidence of Treatment-Emergent Adverse Events
Other study objectives
Evaluation of a novel expanded ectopy scale in exercise stress tests which qualifies both the ectopy and the heart rate at which it occurs.
Evaluation of heart rhythm throughout treatment periods
The pharmacokinetics (PK) of a 28-day administration of S48168 (ARM210) in patients
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: S48168 (ARM210) once daily for 28 daysExperimental Treatment1 Intervention
Oral dose of S48168 (ARM210) once daily on top of standard of care regimen for 28 days.
Group II: Matching Placebo once daily for 28 daysPlacebo Group1 Intervention
Oral dose of placebo once daily on top of standard of care regimen for 28 days.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) is a condition characterized by abnormal heart rhythms triggered by physical activity or stress, often due to mutations in the Ryanodine Receptor (RyR2) calcium release channels. These mutations cause the channels to become 'leaky,' leading to abnormal calcium handling in heart cells, which can precipitate dangerous arrhythmias.
Treatments for CPVT aim to stabilize these channels and prevent arrhythmias. Beta-blockers are commonly used to reduce the heart's response to adrenaline, thereby lowering the risk of arrhythmias.
Flecainide, an antiarrhythmic drug, can also be used to block abnormal electrical activity. The novel drug S48168 (ARM210) specifically targets and repairs the leaky RyR2 channels, addressing the root cause of CPVT.
This mechanism is crucial as it directly corrects the defective calcium handling, potentially offering a more effective and targeted treatment option for CPVT patients.
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Who is running the clinical trial?
Armgo Pharma, Inc.Lead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
Food and Drug Administration (FDA)FED
179 Previous Clinical Trials
1,543,623 Total Patients Enrolled
Michael J Ackerman, MD PhDPrincipal InvestigatorMayo Clinic
Media Library
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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