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Small Molecule Drug

ARM210 for Ventricular Tachycardia

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Study Summary

This trial is testing a new drug, S48168 (ARM210), to see if it is safe and effective in treating Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT1). This disease causes fatal changes in heart rhythms, leading to sudden death with exercise or excitement. The new drug is designed to repair the leaky channels that cause the disease. If it is effective, it would allow people with CPVT to live normal, active lives.

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.Check my eligibility

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.See study design

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

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 outcome measures

Incidence of Treatment-Emergent Adverse Events

Other outcome measures

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 more

Trial 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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Armgo Pharma, Inc.Lead Sponsor

1 Previous Clinical Trials

10 Total Patients Enrolled

Food and Drug Administration (FDA)FED

171 Previous Clinical Trials

1,331,586 Total Patients Enrolled

Michael J Ackerman, MD PhDPrincipal InvestigatorMayo Clinic

Media Library

Catecholaminergic Polymorphic Ventricular Tachycardia Clinical Trial 2023: S48168 (ARM210) Highlights & Side Effects. Trial Name: NCT05122975 — Phase 2

S48168 (ARM210) (Small Molecule Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05122975 — Phase 2

Frequently Asked Questions

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

Who is eligible to join this research study?

"This clinical trial is in search of 20 people aged 12 to 65 with catecholaminergic polymorphic ventricular tachycardia type 1. To qualify, individuals must meet the following criteria: possess a medically-confirmed genetic diagnosis and corresponding phenotype from their last exercise stress test; be able and willing to comply fully with all procedures within the study; depending on gender, utilize an approved method of contraception or provide documentation for recently completed vasectomy procedure; have a BMI ≤36 at screening; exhibit CYP2C8 extensive or intermediate metabolizer genotype; receive preapproval for any medications/dietary supplements they are using"

Answered by AI

Are there any potential hazards associated with S48168 (ARM210) for people who take it?

"Due to the Phase 2 status of S48168 (ARM210), there is some evidence for safety but none for efficacy, thus Power's assessment yields a score of 2."

Answered by AI

Are elderly individuals excluded from participating in this medical experiment?

"This medical study is looking for participants aged 12 to 65. In addition, there are 14 trials specifically tailored towards those under the age of 18 and 95 additional studies targeting an elder demographic."

Answered by AI

Are enrollment procedures still available for this experiment?

"As indicated by the clinicaltrials.gov records, this medical study is no longer recruiting patients. First posted on October 1st 2022 and last updated on July 14th 2022, 120 alternative trials are currently enrolling participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of an Inherited Ventricular Arrhythmia

2023. "Treatment of an Inherited Ventricular Arrhythmia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05122975.