In short
Clinical trials are investigating Vibegron in children and teens with neurogenic detrusor overactivity (NDO) who use clean intermittent catheterization (CIC). These studies look at long-term safety, efficacy, and pharmacokinetics, which means how the body handles the study drug. The main goal is to learn whether treatment improves bladder function in this patient group.
Key points
- Clinical trials of Vibegron are being done in children and teens with neurogenic detrusor overactivity (NDO) who use clean intermittent catheterization (CIC). The main study is a Phase 4, open-label trial in patients 2 years to less than 18 years old. It is looking at long-term safety, efficacy, and pharmacokinetics. The main outcome is change in maximum cystometric capacity (MCC), measured during bladder filling tests. The trial is authorised and plans to include 101 participants.
Trial overview
The available clinical trial for Vibegron is an open-label, long-term study in pediatric patients with neurogenic detrusor overactivity (NDO) who are on clean intermittent catheterization (CIC). The study is designed to evaluate safety, efficacy, and pharmacokinetics in children and teens from 2 years to less than 18 years of age.
Who can participate
This trial is for pediatric subjects, meaning children and adolescents, who are at least 2 years old but younger than 18 years old. The study also requires NDO and use of CIC, so it is focused on a very specific patient group with bladder problems related to nerve conditions.
The trial title also shows that the study is open-label and long-term, which means participants stay in the study for an extended period and know what treatment they are receiving.
What is being measured
The main outcome is the change from baseline at Study Week 32 in maximum cystometric capacity (MCC) based on filling urodynamics. Baseline means the starting point before treatment, and filling urodynamics is a bladder test that measures how the bladder fills and stores urine.
This outcome helps researchers see whether the bladder can hold more urine after treatment, which is an important sign of bladder function in NDO. The study brief summary also says the purpose is to evaluate the efficacy of once-daily Vibegron in pediatric subjects with NDO.
Trial design and phase
This is an interventional study, which means participants receive a study drug so researchers can measure its effects. It is a Phase 4 trial, which is usually a later stage of research and often focuses on more detailed safety and effectiveness information in a defined patient group.
The intervention list shows Vibegron given by mouth in several strengths, including 5 mg, 10 mg, 20 mg, 50 mg, and 75 mg. The source data does not provide more detail on how these doses are assigned, so the main point is that the study is testing oral Vibegron in this pediatric population.
Study status and size
The study status is listed as Authorised, showing that the trial has been approved to proceed. The planned enrollment is 101 participants, which gives an idea of the study size.
Because this is a single trial in the source data, the current evidence base here is focused on one pediatric NDO study rather than a large set of different trials.
Patient terms explained
Neurogenic detrusor overactivity means the bladder muscle becomes overactive because of a nerve-related problem. Clean intermittent catheterization means using a catheter at set times to empty the bladder.
Pharmacokinetics means how the body takes in, changes, and removes a medicine. Urodynamics means bladder testing that helps doctors and researchers understand how the bladder stores urine and how much it can hold.