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Vibegron

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.

Table of Contents

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).[1] The study is designed to evaluate safety, efficacy, and pharmacokinetics in children and teens from 2 years to less than 18 years of age.[1]

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.[1] 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.[1]

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.[1]

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.[1] Baseline means the starting point before treatment, and filling urodynamics is a bladder test that measures how the bladder fills and stores urine.[1]

This outcome helps researchers see whether the bladder can hold more urine after treatment, which is an important sign of bladder function in NDO.[1] The study brief summary also says the purpose is to evaluate the efficacy of once-daily Vibegron in pediatric subjects with NDO.[1]

Trial design and phase

This is an interventional study, which means participants receive a study drug so researchers can measure its effects.[1] 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.[1]

The intervention list shows Vibegron given by mouth in several strengths, including 5 mg, 10 mg, 20 mg, 50 mg, and 75 mg.[1] 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.[1]

Study status and size

The study status is listed as Authorised, showing that the trial has been approved to proceed.[1] The planned enrollment is 101 participants, which gives an idea of the study size.[1]

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.[1]

Patient terms explained

Neurogenic detrusor overactivity means the bladder muscle becomes overactive because of a nerve-related problem.[1] Clean intermittent catheterization means using a catheter at set times to empty the bladder.[1]

Pharmacokinetics means how the body takes in, changes, and removes a medicine.[1] Urodynamics means bladder testing that helps doctors and researchers understand how the bladder stores urine and how much it can hold.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05491525 Phase 4 Neurogenic Detrusor Overactivity (NDO) Authorised 101

FAQ

  • What condition is being studied with Vibegron? The trial is studying neurogenic detrusor overactivity (NDO), a bladder problem caused by nerve-related conditions. It focuses on children and teens who also use clean intermittent catheterization (CIC).
  • Who can take part in the Vibegron trial? The study includes pediatric subjects from 2 years to less than 18 years of age. They must have NDO and be on CIC.
  • What is the main purpose of this trial? The trial is designed to check long-term safety, efficacy, and pharmacokinetics. In simple words, it looks at whether the treatment works, how safe it is, and how the body processes it.
  • What phase is the Vibegron study? This is a Phase 4 trial. Phase 4 studies usually happen after a treatment is already being used and help collect more information in real-world-like patient groups.
  • What outcome is the study measuring? The main outcome is change in maximum cystometric capacity (MCC) at Study Week 32. MCC is the most the bladder can hold during a filling test called urodynamics.

Ongoing Clinical Trials on Vibegron

  • Study on the Safety and Effectiveness of Vibegron for Children Aged 2 to 17 with Neurogenic Bladder Overactivity Using Clean Intermittent Catheterization

    Recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Croatia Denmark Latvia Lithuania Norway +3

Glossary

  • Neurogenic Detrusor Overactivity (NDO): A bladder condition caused by nerve problems, where the bladder muscle squeezes too often or too early.
  • Clean Intermittent Catheterization (CIC): A method of emptying the bladder by using a catheter at set times during the day.
  • Pediatric subjects: Children and teenagers. In this trial, this means patients from 2 years to less than 18 years of age.
  • Phase 4: A later stage of clinical research that studies a treatment in more patients and collects more safety and effectiveness data.
  • Safety: Information about how well a treatment is tolerated and whether it causes unwanted problems.
  • Efficacy: How well a treatment works for the condition being studied.
  • Pharmacokinetics: How the body absorbs, changes, and removes a study drug.
  • Urodynamics: A set of bladder tests that measure how the bladder stores and releases urine.
  • Maximum cystometric capacity (MCC): The largest amount of fluid the bladder can hold during a bladder filling test.
  • Study Week 32: A time point in the trial when results are checked after 32 weeks of study treatment.
  • Open-label: A study design where both the researchers and participants know what treatment is being given.
  • Interventional study: A clinical trial where participants receive a study treatment so researchers can measure its effects.

References