ARM210 for Ventricular Tachycardia

Recruiting at 1 trial location

Overseen By Eugene E Marcantonio, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Armgo Pharma, Inc.

Must be taking: CPVT standard-of-care

Must not be taking: CYP2C8 inducers/inhibitors, Antacids

Disqualifiers: Alcoholism, Epileptic seizures, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

8 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol requires that any daily medicines and dietary supplements be approved by the study's principal investigator and sponsor. Some medications may need a washout period (time without taking certain medications) before joining the study.

What data supports the effectiveness of the drug ARM210 for treating ventricular tachycardia?

The research does not provide direct evidence for ARM210, but it mentions that amiodarone, a similar antiarrhythmic drug, has shown some effectiveness in controlling ventricular tachycardia and reducing sudden cardiac death in certain patients. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Michael J Ackerman, MD PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I have CPVT1 with symptoms, even on my current treatment.

I cannot become pregnant.

My daily medications and supplements are approved for the trial, or I can stop them before joining.

Exclusion Criteria

Participation in clinical trials for other therapeutic investigational drugs simultaneously or within the 4 weeks prior to the first dose of study drug

I can avoid taking non-approved medicines or supplements starting 2 weeks before and during the study.

I am not mentally or legally able to make decisions at the time of screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive S48168 (ARM210) or placebo once daily for 28 days to assess safety, tolerability, and preliminary efficacy

4 weeks

Continuous monitoring with wearable cardiac device

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Matching Placebo
• S48168 (ARM210)

Trial Overview 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.

Participant Groups

Group I: S48168 (ARM210) once daily for 28 days Experimental Treatment 1 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 days Placebo Group 1 Intervention

Oral dose of placebo once daily on top of standard of care regimen for 28 days.

Who Is Running the Clinical Trial?

Armgo Pharma, Inc.

Lead Sponsor

Trials

2

Recruited

20+

Food and Drug Administration (FDA)

Collaborator

Trials

184

Recruited

1,553,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Management and prophylaxis of life-threatening arrhythmias--recent achievements. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Long-term outcome of pharmacological and nonpharmacological treatment for ventricular arrhythmias]. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation and treatment strategies in patients at high risk of sudden death post myocardial infarction. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of amiodarone for refractory supraventricular tachyarrhythmias. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Predicting and preventing sudden death from cardiac causes. [2019]