Adults 3 to 17, any sex, with Neurogenic Detrusor Overactivity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24Primary· Baseline and week 24
Change from baseline in MCC was based on filling urodynamics (volume at the end of filling). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. Missing MCC observations at week 24 were imputed using last observation carried forward (LOCF).
Group
Value
95% CI
Children (3 to < 12 Years)
72.09
± 87.09
Adolescents (12 to < 18 Years)
113.21
± 82.99
Change From Baseline in Bladder Compliance (ΔV/ΔP)Secondary· Baseline and weeks 4 and 24
Bladder compliance was an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder. Change from baseline in bladder compliance (change in volume/change in pressure) was assessed by the independent central reviewers and reported as annotations on the urodynamic trace and in an external database. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135
Change at Week 4
Group
Value
95% CI
Children (3 to < 12 Years)
-4.09
± 50.78
Adolescents (12 to < 18 Years)
15.16
± 22.69
Change at Week 24
Group
Value
95% CI
Children (3 to < 12 Years)
14.62
± 42.09
Adolescents (12 to < 18 Years)
13.59
± 15.02
Change From Baseline in Maximum Cystometric Capacity at Week 4Secondary· Baseline and week 4
Change from baseline in MCC was based on filling urodynamics (volume at the end of filling). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers.
Group
Value
95% CI
Children (3 to < 12 Years)
41.36
± 71.64
Adolescents (12 to < 18 Years)
80.78
± 96.15
Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cm H20) Until End of FillingSecondary· Baseline and weeks 4 and 24
Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers.
Change at Week 4
Group
Value
95% CI
Children (3 to < 12 Years)
0.44
± 5.82
Adolescents (12 to < 18 Years)
-0.64
± 2.94
Change at Week 24
Group
Value
95% CI
Children (3 to < 12 Years)
-1.86
± 4.16
Adolescents (12 to < 18 Years)
-0.77
± 3.87
Change From Baseline in Detrusor Pressure at End of FillingSecondary· Baseline and weeks 4 and 24
Detrusor pressure was defined as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. Filling was stopped (end of filling) when the detrusor pressure exceeded 100 cm H2O or was considered dangerously high by the investigator or urodynamicist (for instance, a prolonged passive detrusor pressure \> 40 cm H2O). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynami
Change at Week 4
Group
Value
95% CI
Children (3 to < 12 Years)
-12.38
± 19.56
Adolescents (12 to < 18 Years)
-6.48
± 30.70
Change at Week 24
Group
Value
95% CI
Children (3 to < 12 Years)
-18.11
± 19.97
Adolescents (12 to < 18 Years)
-13.19
± 19.91
Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20)Secondary· Baseline and weeks 4 and 24
Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of \> 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity.
Change at Week 4
Group
Value
95% CI
Children (3 to < 12 Years)
54.00
13.00 – 105.30
Adolescents (12 to < 18 Years)
41.15
3.00 – 62.50
Change at Week 24
Group
Value
95% CI
Children (3 to < 12 Years)
68.00
32.00 – 110.0
Adolescents (12 to < 18 Years)
62.00
4.00 – 95.15
Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Wilcoxon Signed-rank Test Updated AnalysisSecondary· Baseline and weeks 4 and 24
Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of \> 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity. This updated analysis is presented as the original
Change at Week 4
Group
Value
95% CI
Children (3 to < 12 Years)
48.00
5.00 – 88.00
Adolescents (12 to < 18 Years)
46.30
-23.90 – 176.00
Change at Week 24
Group
Value
95% CI
Children (3 to < 12 Years)
76.00
32.00 – 147.20
Adolescents (12 to < 18 Years)
78.45
26.00 – 176.50
Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Paired T-testSecondary· Baseline and weeks 4 and 24
Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of \> 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity.
Change at Week 4
Group
Value
95% CI
Children (3 to < 12 Years)
56.09
± 96.23
Adolescents (12 to < 18 Years)
73.80
± 117.21
Change at Week 24
Group
Value
95% CI
Children (3 to < 12 Years)
93.09
± 88.14
Adolescents (12 to < 18 Years)
121.33
± 159.84
Change From Baseline in Average Catheterized Volume Per CatheterizationSecondary· Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
For each participant, the average catheterized volume per catheterization was calculated as the sum of all available/non-missing catheterized volumes recorded over 2 measuring days in the weekend diary, whether or not the 2 days were consecutive divided by the number of catheterizations with non-missing volumes. If volumes were recorded on 1 single day of the weekend diary, the average catheterized volume per catheterization was calculated using all available/non-missing catheterized volumes recorded that day. If no volumes were recorded on any day of the weekend diary, the average catheterize
Change at Week 2
Group
Value
95% CI
Children (3 to < 12 Years)
14.58
± 43.98
Adolescents (12 to < 18 Years)
35.99
± 54.19
Change at Week 4
Group
Value
95% CI
Children (3 to < 12 Years)
30.08
± 49.50
Adolescents (12 to < 18 Years)
51.96
± 64.71
Change at Week 8
Group
Value
95% CI
Children (3 to < 12 Years)
36.90
± 46.05
Adolescents (12 to < 18 Years)
45.10
± 53.77
Change at Week 12
Group
Value
95% CI
Children (3 to < 12 Years)
32.25
± 45.51
Adolescents (12 to < 18 Years)
43.94
± 58.49
Change at Week 24
Group
Value
95% CI
Children (3 to < 12 Years)
41.63
± 58.03
Adolescents (12 to < 18 Years)
59.31
± 82.22
Change at Week 36
Group
Value
95% CI
Children (3 to < 12 Years)
53.87
± 91.74
Adolescents (12 to < 18 Years)
52.14
± 74.90
Change at Week 52
Group
Value
95% CI
Children (3 to < 12 Years)
42.84
± 65.31
Adolescents (12 to < 18 Years)
42.40
± 69.25
Change From Baseline in Maximum Catheterized VolumeSecondary· Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
For each participant, the maximum catheterized volume per day was calculated using all available/non-missing catheterized volumes recorded for the 2 measuring days in the weekend e-diary, whether or not these 2 days were consecutive. Maximum value was calculated separately for each measuring day and the mean of the two values was used. If volumes recorded on 1 single day of the weekend e-diary, the maximum catheterized volume per day was calculated using all available/non-zero catheterized volumes recorded that day. If no volumes were recorded on any day of the weekend e-diary, the maximum cat
Change at Week 2
Group
Value
95% CI
Children (3 to < 12 Years)
17.50
± 73.58
Adolescents (12 to < 18 Years)
42.38
± 78.23
Change at Week 4
Group
Value
95% CI
Children (3 to < 12 Years)
46.69
± 80.29
Adolescents (12 to < 18 Years)
73.25
± 103.98
Change at Week 8
Group
Value
95% CI
Children (3 to < 12 Years)
45.27
± 75.22
Adolescents (12 to < 18 Years)
42.86
± 79.97
Change at Week 12
Group
Value
95% CI
Children (3 to < 12 Years)
33.23
± 68.31
Adolescents (12 to < 18 Years)
47.29
± 69.83
Change at Week 24
Group
Value
95% CI
Children (3 to < 12 Years)
49.88
± 103.70
Adolescents (12 to < 18 Years)
84.39
± 121.98
Change at Week 36
Group
Value
95% CI
Children (3 to < 12 Years)
60.09
± 121.66
Adolescents (12 to < 18 Years)
54.78
± 104.54
Change at Week 52
Group
Value
95% CI
Children (3 to < 12 Years)
53.51
± 96.72
Adolescents (12 to < 18 Years)
54.30
± 104.74
Change From Baseline in Maximum Catheterized Daytime Volume (MCDV)Secondary· Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
For each participant, the MCDV was calculated using all available/non-missing catheterized daytime volumes for the 2 measuring days in the weekend e-diary, whether or not the 2 days were consecutive. Maximum value was calculated separately for each measuring day and the mean of the 2 values was used. If volumes were recorded on 1 single day of the weekend e-diary, the MCDV was calculated using all available/non-zero catheterized daytime volumes recorded that day. If no volumes were recorded on any day of the weekend e-diary, the MCDV was missing. Daytime was defined as the time between wake-up
Change at Week 2
Group
Value
95% CI
Children (3 to < 12 Years)
18.13
± 73.38
Adolescents (12 to < 18 Years)
35.58
± 86.78
Change at Week 4
Group
Value
95% CI
Children (3 to < 12 Years)
37.71
± 83.33
Adolescents (12 to < 18 Years)
70.35
± 113.98
Change at Week 8
Group
Value
95% CI
Children (3 to < 12 Years)
43.91
± 74.44
Adolescents (12 to < 18 Years)
38.11
± 90.88
Change at Week 12
Group
Value
95% CI
Children (3 to < 12 Years)
29.05
± 67.86
Adolescents (12 to < 18 Years)
43.04
± 73.82
Change at Week 24
Group
Value
95% CI
Children (3 to < 12 Years)
44.20
± 98.31
Adolescents (12 to < 18 Years)
81.37
± 117.77
Change at Week 36
Group
Value
95% CI
Children (3 to < 12 Years)
58.49
± 121.12
Adolescents (12 to < 18 Years)
50.90
± 114.05
Change at Week 52
Group
Value
95% CI
Children (3 to < 12 Years)
53.76
± 100.24
Adolescents (12 to < 18 Years)
49.13
± 117.23
Change From Baseline in Average Morning Catheterized VolumeSecondary· Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
The first morning catheterized volume was the first recorded non-zero volume within or after the hour of the wake-up time on a volume-measuring day in the e-diary. The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the weekend e-diary, whether or not these 2 days were consecutive. If the first morning catheterized volume was recorded on 1 single day of the weekend e-diary, the average morning catheterized is the first morning catheterized that day. If no first morning catheterized
Change at Week 2
Group
Value
95% CI
Children (3 to < 12 Years)
7.98
± 101.36
Adolescents (12 to < 18 Years)
39.52
± 80.24
Change at Week 4
Group
Value
95% CI
Children (3 to < 12 Years)
19.81
± 89.04
Adolescents (12 to < 18 Years)
75.25
± 105.72
Change at Week 8
Group
Value
95% CI
Children (3 to < 12 Years)
34.01
± 89.53
Adolescents (12 to < 18 Years)
44.43
± 89.01
Change at Week 12
Group
Value
95% CI
Children (3 to < 12 Years)
8.68
± 80.16
Adolescents (12 to < 18 Years)
38.23
± 66.80
Change at Week 24
Group
Value
95% CI
Children (3 to < 12 Years)
40.76
± 116.41
Adolescents (12 to < 18 Years)
86.66
± 96.55
Change at Week 36
Group
Value
95% CI
Children (3 to < 12 Years)
31.08
± 145.63
Adolescents (12 to < 18 Years)
68.47
± 122.43
Change at Week 52
Group
Value
95% CI
Children (3 to < 12 Years)
31.83
± 94.25
Adolescents (12 to < 18 Years)
38.14
± 108.06
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study drug administration up to end-of-treatment (EoT) (up to week 52)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Children (3 to < 12 Years)
Serious: 9/55 (16%)
Deaths: 0/55
Adolescents (12 to < 18 Years)
Serious: 5/31 (16%)
Deaths: 0/31
Serious adverse events (18 terms)
Reaction
System
Children (3 to < 12 Years)
Adolescents (12 to < 18 Ye…
Device malfunction
General disorders
—
—
Talipes
Congenital, familial and genetic disorders
—
—
Colitis
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Appendicitis
Infections and infestations
—
—
Bronchitis
Infections and infestations
—
—
Escherichia urinary tract infection
Infections and infestations
—
—
Pneumonia bacterial
Infections and infestations
—
—
Pyelonephritis acute
Infections and infestations
—
—
Viral infection
Infections and infestations
—
—
Shunt malfunction
Injury, poisoning and procedural complications
—
—
Benign neoplasm of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The objective of the study was to evaluate the efficacy, safety, tolerability and pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT05713799 — Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
· Phase 2
· not yet recruiting
NCT07310797 — Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
· Phase 4
· not yet recruiting
NCT06534762 — Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study
· Phase 2
· recruiting
NCT06551246 — Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
· Phase 3
· recruiting
NCT06465576 — Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)
· Phase 4
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Europe B.V.
Last refreshed: 12 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02751931.