NCT02751931

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

An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a phase 3, open-label, baseline-controlled, multicenter study. The study consisted of 3 periods: Pretreatment period: for a maximum of 28 days before baseline, including screening, washout (if applicable) and baseline. Efficacy treatment period: beginning the day after baseline and continuing to week 24. Long-term safety period: beginning after week 24 and continuing to week 52 (end of study \[EOS\]), or to the end of treatment (EOT).

Conditions

• Neurogenic Detrusor Overactivity

Interventions

Type	Name	Description
DRUG	Mirabegron	Participants received initial dose of 25 mg of mirabegron PED25 orally once daily. At weeks 2, 4 or 8, participants were up-titrated to PED50 based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT. Participants with a body weight \>=35 kg received mirabegron tablets or body weight \<35 kg received mirabegron oral suspension. At week 24, participants on mirabegron oral suspension could switch to tablets if the body weight became \>=35 kg or participants on mirabegron tablets could switch to oral suspension if the body weight became \<35 Kg or participants could switch to either of the dosage form for acceptability reasons after sponsor's prior approval and on a case-by-case basis. Mirabegron extended-release granules were reconstituted with water to prepare a mirabegron oral suspension of 8 mg/mL. Administration was via an oral syringe with a sip of water afterwards.

Timeline

• Start date: 2016-06-17
• Primary completion: 2018-11-05
• Completion: 2019-05-06
• First posted: 2016-04-26
• Last updated: 2024-11-12
• Results posted: 2020-05-12

Locations

32 sites across 19 countries: Australia, Belgium, Croatia, Denmark, Israel, Jordan, Latvia, Lithuania, Malaysia, Mexico, Norway, Philippines, Poland, Romania, Serbia, Slovakia, South Korea, Taiwan, Turkey (Türkiye)