Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05621616 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed 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 Show 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
  2. Minor Re-verified, no change to tracked fieldsv29
  3. Minor Study sites: 4 to 3 Primary completion date changed from estimate of Feb 28, 2026 to Feb 16, 2026v28 Show 1 more changeShow less
    • Primary completion date changed from estimate of Feb 28, 2026 to Feb 16, 2026
  4. Minor Re-verified, no change to tracked fieldsv27
  5. Minor Study sites: 7 to 4v26
Show 24 earlier versionsHide 24 earlier versions
  1. Minor Study sites: 13 to 7 Primary completion date: Dec 31, 2025 to Feb 28, 2026 · Completion date: Jul 31, 2026 to Sep 30, 2026v25 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2025 to Feb 28, 2026
    • Completion date: Jul 31, 2026 to Sep 30, 2026
  2. Notable Enrollment target: 10 to 7 Trial status: Recruiting to Active, Not Recruiting · Completion date: Sep 30, 2026 to Jul 31, 2026 · Site details revised at 13 of 13 sitesv24 Show 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
  3. Minor Study sites: 11 to 13v23
  4. Notable Primary completion date: Feb 28, 2025 to Dec 31, 2025 Completion date: Jun 30, 2026 to Sep 30, 2026v22 Show 1 more changeShow less
    • Completion date: Jun 30, 2026 to Sep 30, 2026
  5. Minor Study sites: 9 to 11v21
  6. Minor Study sites: 7 to 9v20
  7. Minor Secondary endpoints: details revised at 1 of 20 entries Eligibility criteria expanded, about 2 wordsv19 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  8. Minor Re-verified, no change to tracked fieldsv18
  9. Minor Study title expanded, about 25 wordsv17 See this version in full on ClinicalTrials.gov ↗
  10. Minor 2 versions Re-verified since Aug 2, 2024, no change to tracked fieldsv15-v16
  11. Notable Primary completion date: Jun 30, 2026 to Feb 28, 2025 Study sites: 6 to 7v14 Show 1 more changeShow less
    • Study sites: 6 to 7
  12. Minor Study sites: 5 to 6 Primary and study completion dates: Jul 31, 2026 to Jun 30, 2026v13 Show 1 more changeShow less
    • Primary and study completion dates: Jul 31, 2026 to Jun 30, 2026
  13. Notable Start date: Jun 26, 2023 to Feb 28, 2024 Primary completion date: May 31, 2026 to Jul 31, 2026 · Completion date: Jun 30, 2026 to Jul 31, 2026v12 Show 2 more changesShow less
    • Primary completion date: May 31, 2026 to Jul 31, 2026
    • Completion date: Jun 30, 2026 to Jul 31, 2026
  14. Minor Study sites: 2 to 5 Primary completion date: Jul 31, 2026 to May 31, 2026 · Completion date: Aug 31, 2026 to Jun 30, 2026v11 Show 2 more changesShow less
    • Primary completion date: Jul 31, 2026 to May 31, 2026
    • Completion date: Aug 31, 2026 to Jun 30, 2026
  15. Minor Primary completion date: May 31, 2026 to Jul 31, 2026 Completion date: Jun 30, 2026 to Aug 31, 2026 · Eligibility criteria expanded, about 7 wordsv10 Show 2 more changesShow less
    • Completion date: Jun 30, 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  16. Minor Eligibility criteria expanded, about 25 wordsv9 See this version in full on ClinicalTrials.gov ↗
  17. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 31, 2024 to May 31, 2026 · Study sites: 0 to 2 · Completion date: Jul 31, 2025 to Jun 30, 2026 · 1 morev8 Show 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
  18. Notable Start date: May 31, 2023 to Aug 31, 2023 Primary completion date: Jan 31, 2025 to Dec 31, 2024 · Completion date: Jun 30, 2025 to Jul 31, 2025v7 Show 2 more changesShow less
    • Primary completion date: Jan 31, 2025 to Dec 31, 2024
    • Completion date: Jun 30, 2025 to Jul 31, 2025
  19. Notable Start date: Apr 30, 2023 to May 31, 2023 Completion date: Aug 31, 2025 to Jun 30, 2025v6 Show 1 more changeShow less
    • Completion date: Aug 31, 2025 to Jun 30, 2025
  20. Notable Start date: Mar 31, 2023 to Apr 30, 2023v5
  21. Notable Start date: Jan 31, 2023 to Mar 31, 2023 Study sites: 12 to 0 · Primary completion date: Sep 30, 2025 to Jan 31, 2025 · Completion date: Sep 30, 2025 to Aug 31, 2025v4 Show 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
  22. Notable Start date: Dec 31, 2022 to Jan 31, 2023v3
  23. Notable Start date: Nov 30, 2022 to Dec 31, 2022 Primary and study completion dates: Aug 31, 2025 to Sep 30, 2025v2 Show 1 more changeShow less
    • Primary and study completion dates: Aug 31, 2025 to Sep 30, 2025
  1. Minor Study 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.
Trial Details
NCT Number NCT05621616
Lead Sponsor Astellas Pharma Global Development, Inc.
Conditions Neurogenic Detrusor Overactivity
Enrollment 7 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov