Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity

NCT02751931 ↗

Phase 3 Completed 91 enrolled Astellas Pharma Europe B.V.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The objective of the study was to evaluate the efficacy, safety, tolerability and pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.

Timeline

Start: 2016-06-17
Primary completion: 2018-11-05
Completion: 2019-05-06

Outcome

Met primary endpoint

paper A statistically significant increase in MCC from baseline to Week 24 was observed (87.20 ml, 95% confidence interval: 66.07, 108.33; p < .001); PMID 34058027 ↗

Publications

Baka-Ostrowska M, Bolong DT, Persu C, Tondel C, Steup A, Lademacher C, Martin N. Efficacy and safety of mirabegron in children and adolescents with neurogenic detrusor overactivity: An open-label, phase 3, dose-titration study. Neurourol Urodyn. 2021 Aug;40(6):1490-1499. doi: 10.1002/nau.24657. Epub 2021 May 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirabegron	Other / unclassified	25 mg	Oral
Subject	Mirabegron	Other / unclassified	50 mg	Oral