A Phase 3, Open Label, Multicenter, Baseline-controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron Prolonged-release Microgranula-based Suspension in Children from 6 Months to Less Than 3 Years of Age with Neurogenic Detrusor Overactivity

Neurogenic detrusor overactivity (NDO)

Change from baseline in MCC after 24 weeks of study intervention (based on filling urodynamics)

Change from baseline in urodynamic measures: o Bladder compliance (ΔV/ΔP) at weeks 4 and 24 o Filling volume until first detrusor contraction (> 15 cm H2O) at weeks 4 and 24 o Number of uninhibited detrusor contractions until leakage or until maximum 135% of age-related bladder capacity, Change from baseline in e-diary measures: o Maximum and average catheterized daytime volume o Average morning catheterized volume (based on first catheterization after participant woke up) o Number of leakage episodes (per 24 h) o Number of dry (leakage-free) days per 7 days, Acceptability by P-OMAQ-C at weeks 4, 24, and 52, AEs, Vital signs, on site and SBPM; SBPM from baseline to EOS, Clinical laboratory tests (hematology, coagulation, biochemistry, eGFR, urinalysis), 12-lead ECG, Upper urinary tract ultrasound, AUC24, Ctrough, CL/F, VZ/F, Cmax and Tmax, Additional PK parameters may be calculated based on the model used

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