Trial · NCT05621616
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
NCT05621616, Phase 3, Completed, Astellas Pharma Global Development, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT05621616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05621616
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT05621616
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Neurogenic Detrusor Overactivity
- Interventions
- mirabegron
- First posted
- 2022-11-18
- Last updated
- 2026-10-01
- Other registries' IDs
- eudract:2021-005455-37
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) | Baseline and week 24 | MCC is maximum bladder capacity reached at end of filling cytometry. |
| Secondary | Change from baseline in bladder compliance | Baseline and weeks 4 and 24 | Bladder compliance is calculated by change in volume divided by change in pressure during filling of the bladder. |
| Secondary | Change from baseline in filling volume until first detrusor contraction (>15cm H2O) | Baseline and weeks 4 and 24 | Change in bladder volume calculated by urodynamic assessments. |
| Secondary | Change from baseline in number of uninhibited detrusor contractions until leakage or until maximum 135% of age-related bladder capacity | Baseline and weeks 4 and 24 | Change in number of of uninhibited detrusor contractions is calculated by urodynamic assessments. |
| Secondary | Change from baseline in maximum catheterized daytime volume | Baseline and up to week 52 | Based on participant e-diary. |
| Secondary | Change from baseline in average catheterized daytime volume | Baseline and up to week 52 | Based on participant e-diary. |
| Secondary | Change from baseline in average morning catheterized volume | Baseline and up to week 52 | E-diary measure based on first catheterization after participant wakes up. |
| Secondary | Change from baseline in number of leakage episodes per 24 hours | Baseline and up to week 52 | Based on participant e-diary. |
| Secondary | Change from baseline in number of dry days per 7 days | Baseline and up to week 52 | Based on participant e-diary, dry defined as leakage-free. |
| Secondary | Acceptability by pediatric oral medicine acceptability questionnaire for caregivers (P-OMAQ-C) | Baseline and weeks 4, 24 and 52 | The P-OMAQ-C uses a 5-point numerical rate scale to measure acceptability of use of the tablet formulation with questions related to taste, smell and administration of study medication. Acceptability questionnaires to be completed by caregivers on an electronic device. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05621616
GET https://conductscience.org/api/trials/v1/NCT05621616/registered?page=2