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A Study to Learn How Effective and Safe the Drug 'Mirabegron' is and How Long it Stays in the Body of Children Aged 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity
MinorTrial completedStudy completion date changed from estimate of Sep 30, 2026 to Sep 17, 2026 · Eligibility criteria expanded, about 34 words · Secondary endpoints: details revised at 8 of 20 entriesShow 3 more changesShow less
Study completion date changed from estimate of Sep 30, 2026 to Sep 17, 2026
Eligibility criteria expanded, about 34 words
Secondary endpoints: details revised at 8 of 20 entries
MinorRe-verified, no change to tracked fieldsv29
MinorStudy sites: 4 to 3Primary completion date changed from estimate of Feb 28, 2026 to Feb 16, 2026v28Show 1 more changeShow less
Primary completion date changed from estimate of Feb 28, 2026 to Feb 16, 2026
MinorRe-verified, no change to tracked fieldsv27
MinorStudy sites: 7 to 4v26
Show 24 earlier versionsHide 24 earlier versions
MinorStudy sites: 13 to 7Primary completion date: Dec 31, 2025 to Feb 28, 2026 · Completion date: Jul 31, 2026 to Sep 30, 2026v25Show 2 more changesShow less
Primary completion date: Dec 31, 2025 to Feb 28, 2026
Completion date: Jul 31, 2026 to Sep 30, 2026
NotableEnrollment target: 10 to 7Trial status: Recruiting to Active, Not Recruiting · Completion date: Sep 30, 2026 to Jul 31, 2026 · Site details revised at 13 of 13 sitesv24Show 3 more changesShow less
Trial status: Recruiting to Active, Not Recruiting
Completion date: Sep 30, 2026 to Jul 31, 2026
Site details revised at 13 of 13 sites
MinorStudy sites: 11 to 13v23
NotablePrimary completion date: Feb 28, 2025 to Dec 31, 2025Completion date: Jun 30, 2026 to Sep 30, 2026v22Show 1 more changeShow less
Completion date: Jun 30, 2026 to Sep 30, 2026
MinorStudy sites: 9 to 11v21
MinorStudy sites: 7 to 9v20
MinorSecondary endpoints: details revised at 1 of 20 entriesEligibility criteria expanded, about 2 wordsv19Show 1 more changeShow less
Minor2 versionsRe-verified since Aug 2, 2024, no change to tracked fieldsv15-v16
NotablePrimary completion date: Jun 30, 2026 to Feb 28, 2025Study sites: 6 to 7v14Show 1 more changeShow less
Study sites: 6 to 7
MinorStudy sites: 5 to 6Primary and study completion dates: Jul 31, 2026 to Jun 30, 2026v13Show 1 more changeShow less
Primary and study completion dates: Jul 31, 2026 to Jun 30, 2026
NotableStart date: Jun 26, 2023 to Feb 28, 2024Primary completion date: May 31, 2026 to Jul 31, 2026 · Completion date: Jun 30, 2026 to Jul 31, 2026v12Show 2 more changesShow less
Primary completion date: May 31, 2026 to Jul 31, 2026
Completion date: Jun 30, 2026 to Jul 31, 2026
MinorStudy sites: 2 to 5Primary completion date: Jul 31, 2026 to May 31, 2026 · Completion date: Aug 31, 2026 to Jun 30, 2026v11Show 2 more changesShow less
Primary completion date: Jul 31, 2026 to May 31, 2026
Completion date: Aug 31, 2026 to Jun 30, 2026
MinorPrimary completion date: May 31, 2026 to Jul 31, 2026Completion date: Jun 30, 2026 to Aug 31, 2026 · Eligibility criteria expanded, about 7 wordsv10Show 2 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingPrimary completion date: Dec 31, 2024 to May 31, 2026 · Study sites: 0 to 2 · Completion date: Jul 31, 2025 to Jun 30, 2026 · 1 morev8Show 4 more changesShow less
Primary completion date: Dec 31, 2024 to May 31, 2026
Study sites: 0 to 2
Completion date: Jul 31, 2025 to Jun 30, 2026
Start date changed from estimate of Aug 31, 2023 to Jun 26, 2023
NotableStart date: May 31, 2023 to Aug 31, 2023Primary completion date: Jan 31, 2025 to Dec 31, 2024 · Completion date: Jun 30, 2025 to Jul 31, 2025v7Show 2 more changesShow less
Primary completion date: Jan 31, 2025 to Dec 31, 2024
Completion date: Jun 30, 2025 to Jul 31, 2025
NotableStart date: Apr 30, 2023 to May 31, 2023Completion date: Aug 31, 2025 to Jun 30, 2025v6Show 1 more changeShow less
Completion date: Aug 31, 2025 to Jun 30, 2025
NotableStart date: Mar 31, 2023 to Apr 30, 2023v5
NotableStart date: Jan 31, 2023 to Mar 31, 2023Study sites: 12 to 0 · Primary completion date: Sep 30, 2025 to Jan 31, 2025 · Completion date: Sep 30, 2025 to Aug 31, 2025v4Show 3 more changesShow less
Study sites: 12 to 0
Primary completion date: Sep 30, 2025 to Jan 31, 2025
Completion date: Sep 30, 2025 to Aug 31, 2025
NotableStart date: Dec 31, 2022 to Jan 31, 2023v3
NotableStart date: Nov 30, 2022 to Dec 31, 2022Primary and study completion dates: Aug 31, 2025 to Sep 30, 2025v2Show 1 more changeShow less
Primary and study completion dates: Aug 31, 2025 to Sep 30, 2025
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
People with neurogenic detrusor overactivity (NDO) have poor bladder control because of how their nerves to the bladder are wired. This can cause high pressure in the bladder, causing it to leak urine by accident (incontinence). Mirabegron has already been approved for adults with bladder problems and for children 3 years and older. This study will learn if mirabegron can help young children with NDO. The children will be from 6 months to up to 3 years old.
The main aim of this study is to learn if mirabegron increases how much urine the bladder holds (maximum cystometric capacity, or Maximum Cystometric Capacity \[MCC\]) in young children with NDO. An increase in MCC will prevent high pressure in the bladder.
Children from 6 months to up to 3 years old who have NDO can take part. They must weigh 9 kilograms (kg) or more. They will already be fitted with a tube (catheter) in their bladder. They will use this to drain urine from their bladder regularly during the day. This is called clean intermittent catheterization (CIC).
There will be 2 groups in the study. Young children who aren't taking certain medicines for NDO will be in group A. Young children who are taking certain medicines for NDO will be in group B. Children in group B will stop taking these medicines before they start taking mirabegron. Treatment in group B will be delayed to allow the medicines to be cleared from the body before they start taking mirabegron. Both groups (A and B) will have the same treatment and dose of mirabegron and will have the same checks throughout the study.
Mirabegron will be squirted from a syringe into the children's mouths, followed by a sip of water. This will happen once a day for up to 52 weeks (1 year). They will start on a low dose, adjusted for their weight. The dose may be increased to a higher dose if the study doctor thinks the child will benefit from the higher dose.
Children will have safety checks throughout the study. Other tests will include checking how the bladder fills and empties plus an ultrasound of the bladder area.
There will be several clinic visits during the study. There will be fewer clinic visits if a child stays on the low dose of mirabegron. Then, the clinic will phone the caregiver about 1 month after the last dose of mirabegron to check if there are any further medical problems.