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Study on the Safety and Effectiveness of Mirabegron for Children Aged 6 Months to Under 3 Years with Neurogenic Detrusor Overactivity

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Neurogenic Detrusor Overactivity (NDO), which is a type of overactive bladder caused by nerve problems. The study is specifically for children aged 6 months to less than 3 years who have this condition. The treatment being tested is a medication called Mirabegron, which is given as a prolonged-release oral suspension. This means the medicine is in liquid form and is designed to release slowly in the body over time.

The purpose of the study is to evaluate how effective and safe Mirabegron is for treating symptoms of an overactive bladder in young children with a neurological cause. The study will also look at how long the medication stays in the body. Participants will receive the medication in gradually increasing doses, followed by a period where they receive a fixed dose. The study will last for up to 52 weeks, during which the children will be monitored for any changes in their condition and any side effects they might experience.

Throughout the study, various tests and observations will be conducted to assess the medication's impact. These include checking bladder function, monitoring for any leakage episodes, and evaluating the overall acceptability of the treatment. The study will also involve regular health checks, such as vital signs and laboratory tests, to ensure the safety of the participants. The results will help determine if Mirabegron is a suitable treatment option for young children with Neurogenic Detrusor Overactivity.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study involves children aged 6 months to less than 3 years with a condition called neurogenic detrusor overactivity (NDO).

    The child must have a previous condition called myelomeningocele and a confirmed diagnosis of NDO through specific tests.

    The child should be able to swallow the study medication and follow a specific catheterization routine.

  2. Step 2

    Baseline assessment

    Initial tests are conducted to confirm the diagnosis of NDO. This includes measuring bladder pressure and other related assessments.

    The child's weight and ability to follow the study requirements are evaluated.

  3. Step 3

    Medication administration

    The child receives mirabegron in the form of an oral suspension. This medication is designed to help manage bladder activity.

    The dosage is adjusted over time to find the most effective amount for the child.

  4. Step 4

    Observation period

    After the dosage is set, the child continues to take the medication for a fixed period.

    Regular assessments are conducted to monitor the child's response to the medication.

  5. Step 5

    Follow-up assessments

    The child's bladder function is evaluated at specific intervals, such as weeks 4 and 24.

    Additional tests include checking for any side effects, measuring vital signs, and conducting laboratory tests.

  6. Step 6

    End of study

    The study is expected to conclude by June 2026.

    Final assessments are conducted to evaluate the overall effectiveness and safety of the medication.

Who can join the trial?

11 criteria

  • The participant's legal guardian must provide written consent and agree to privacy terms before any study procedures begin.
  • The participant's legal guardian must be willing and able to follow the study requirements, including using an electronic diary and following medication rules.
  • The participant's legal guardian must agree not to let the participant join another study while participating in this one.
  • The participant must be a boy or girl aged between 6 months and less than 3 years old.
  • The participant must weigh at least 6 kilograms.
  • The participant must have a history of myelomeningocele, which is a type of spinal cord defect, documented at the screening visit.
  • The participant must have a diagnosis of neurogenic detrusor overactivity (NDO), confirmed by a test called urodynamic investigation. This means the bladder muscle contracts too much, causing pressure changes.
  • The participant must have a diagnosis of DSD, which stands for detrusor sphincter dyssynergia, a condition where the bladder and sphincter muscles do not work together properly.
  • The participant must be using CIC, which stands for clean intermittent catheterization, a method to help empty the bladder.
  • The participant must be suitable for a routine of 4 to 6 CICs per day, as determined by the study investigator using a 7-day electronic diary.
  • The participant must be able to swallow the study medication.

Who cannot join the trial?

9 criteria

  • Patients who have any other medical condition that might interfere with the study.
  • Patients who are taking medications that could affect the study results.
  • Patients who have had a recent surgery or medical procedure that could impact the study.
  • Patients who are unable to follow the study instructions or attend study visits.
  • Patients who have a history of allergic reactions to the study medication or similar drugs.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a condition that affects their ability to urinate normally, other than the condition being studied.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a serious illness that could affect their participation in the study.
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Investigated drugs

Mirabegron is a medication being studied for its effectiveness and safety in children with neurogenic detrusor overactivity. It is designed to help manage bladder function by relaxing the bladder muscle, which can help reduce symptoms such as frequent urination and urinary incontinence. In this trial, the medication is given in a prolonged-release microgranula-based suspension form, which means it is released slowly over time to maintain a consistent effect.

What is already known about the treatment

Mirabegron – This medication is administered orally in the form of a prolonged-release microgranule-based suspension. It is currently being studied in clinical trials, particularly for its use in children aged 6 months to less than 3 years with neurogenic detrusor overactivity (NDO). The main therapeutic indication for mirabegron is to manage symptoms associated with NDO, a condition that affects bladder function. At the molecular level, mirabegron works by activating beta-3 adrenergic receptors in the bladder, which helps relax the bladder muscle and increase its capacity. It is classified pharmacologically as a beta-3 adrenergic agonist.

Investigated diseases

Neurogenic Detrusor Overactivity – This condition occurs when there is an overactive bladder due to nerve problems, often resulting from neurological disorders. It leads to involuntary bladder contractions during the filling phase, causing a sudden and strong urge to urinate. The bladder may not store urine properly, leading to frequent urination and potential leakage. Over time, this can affect bladder compliance, which is the ability of the bladder to stretch and hold urine. The condition can also impact the volume of urine the bladder can hold before the first involuntary contraction occurs. It is commonly observed in individuals with spinal cord injuries or diseases affecting the nervous system.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-507903-74-00Protocol code178-CL-207Estimated enrolment11 patientsSponsorAstellas Pharma Global Development Inc.

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