Table of Contents
- Clinical trials overview
- Type 1 diabetes studies
- Heart disease and rhythm studies
- Other pediatric study
- Outcomes and endpoints
- Study designs and participants
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.[1][2][3][4][5]
Across these studies, Verapamil is being tested in different ways: alone, compared with placebo, and compared with other active drugs.[1][2][3][4][5]
Type 1 diabetes studies
One Phase 2 study, Image-VER-A-T1D, includes adults with type 1 diabetes and has 30 planned participants.[1] 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.[1]
Another study is a Phase 1 trial in children with recent-onset type 1 diabetes, with 36 planned participants.[3] 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.[3]
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.[3]
Heart disease and rhythm studies
One Phase 3 study in 140 patients examines Verapamil in symptomatic people with non-obstructive hypertrophic cardiomyopathy.[2] 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.[2]
Another Phase 2 pilot trial compares Verapamil with QUINIDINE in short-coupled idiopathic ventricular fibrillation.[4] This open-label, randomized crossover study has 24 planned participants and looks at sustained ventricular arrhythmia using a severity scoring system.[4]
A larger low-intervention study called SUPPRESS includes asymptomatic patients with frequent PVCs and normal LVEF, with 298 planned participants.[5] It tests whether preventive treatment, including Verapamil and other drugs, can lower the risk of later left ventricular dysfunction within 2 years.[5]
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.[6] 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.[6]
Outcomes and endpoints
The main endpoints differ by disease area, but they all focus on measurable signs of benefit or harm.[1][2][3][4][5][6]
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.[1][3]
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.[2][4][5]
In the pediatric neurodevelopment study, the outcome is cognitive testing at 24 months, which checks early brain development and learning skills.[6]
Study designs and participants
The studies use several common research designs, including interventional trials, randomized trials, placebo-controlled trials, and crossover studies.[1][3][4]
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.[1][3][5][6]
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.[2][3][4]
