In short
Clinical trials are investigating Verapamil in several conditions, including type 1 diabetes, hypertrophic cardiomyopathy, ventricular arrhythmias, frequent premature ventricular complexes, and tuberous sclerosis complex. These studies look at safety, effectiveness, and changes in disease measures in different patient groups, including children and adults.
Key points
- Clinical trials of Verapamil in this set are studying several different conditions, not just one disease. The main target groups include children and adults with type 1 diabetes, patients with non-obstructive hypertrophic cardiomyopathy, people with serious heart rhythm disorders, and young children with tuberous sclerosis complex. The studies range from early Phase 1 research to Phase 3 and low-intervention research. The main outcomes include beta cell function, pancreatic imaging results, exercise capacity, heart size and function, arrhythmia events, and neuropsychologic development. Some trials compare Verapamil with placebo, while others compare it with other active treatments.
Clinical trials overview
The trials in this set study Verapamil in several different patient groups, including people with type 1 diabetes, hypertrophic cardiomyopathy, ventricular fibrillation, frequent premature ventricular complexes, and tuberous sclerosis complex.
Across these studies, Verapamil is being tested in different ways: alone, compared with placebo, and compared with other active drugs.
Type 1 diabetes studies
One Phase 2 study, Image-VER-A-T1D, includes adults with type 1 diabetes and has 30 planned participants. It compares treatment with Verapamil and EXENATIDE against a placebo group, and the main goal is to measure pancreatic uptake on PET/CT as a way to estimate beta cell mass before and after treatment.
Another study is a Phase 1 trial in children with recent-onset type 1 diabetes, with 36 planned participants. This double-blind, randomized, placebo-controlled study looks at whether oral Verapamil can help preserve residual insulin secretion, which means the amount of insulin the body still makes after diagnosis.
The main safety endpoint in part A is the frequency of adverse events and serious adverse events during treatment, while part B measures change in C-peptide during a mixed meal tolerance test at month 24.
Heart disease and rhythm studies
One Phase 3 study in 140 patients examines Verapamil in symptomatic people with non-obstructive hypertrophic cardiomyopathy. The study aims to reduce symptoms and arrhythmic complications, and it measures changes in VO2 max, left ventricular end-diastolic volume, and the incidence of non-sustained ventricular tachycardia.
Another Phase 2 pilot trial compares Verapamil with QUINIDINE in short-coupled idiopathic ventricular fibrillation. This open-label, randomized crossover study has 24 planned participants and looks at sustained ventricular arrhythmia using a severity scoring system.
A larger low-intervention study called SUPPRESS includes asymptomatic patients with frequent PVCs and normal LVEF, with 298 planned participants. It tests whether preventive treatment, including Verapamil and other drugs, can lower the risk of later left ventricular dysfunction within 2 years.
Other pediatric study
One Phase 2 study in 64 children under 4 months of age with tuberous sclerosis complex includes Verapamil among several treatment options. The study compares treatment strategies with standard of care alone and measures neuropsychologic outcome at 24 months using Bayley Scales of Infant and Toddler Development III testing.
Outcomes and endpoints
The main endpoints differ by disease area, but they all focus on measurable signs of benefit or harm.
- In diabetes studies, the main outcomes look at pancreatic imaging, beta cell mass, and C-peptide, which help show how much insulin-making function remains.
- In heart studies, the outcomes include exercise capacity, heart chamber size, arrhythmia events, and left ventricular function, which show how well the heart is working.
- In the pediatric neurodevelopment study, the outcome is cognitive testing at 24 months, which checks early brain development and learning skills.
Study designs and participants
The studies use several common research designs, including interventional trials, randomized trials, placebo-controlled trials, and crossover studies.
Participants vary by trial: some studies enroll adults, some enroll children, and some focus on people with no symptoms but a specific heart rhythm finding.
Trial phases also vary, from Phase 1 safety and early testing to Phase 3 larger confirmatory research, showing that Verapamil is being studied at different stages of development for different conditions.