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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

February 28, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

September 30, 2026

Conditions
Neurogenic Detrusor Overactivity
Interventions
DRUG

mirabegron

"Participants will receive mirabegron prolonged-release microgranula-based oral suspension once daily. The initial dose of mirabegron will be based on the participant's weight.~The initial low dose will be up-titrated to a higher dose at weeks 2, 4 or 8 unless the participant is determined to be effectively treated with the low dose, based on urodynamics and the participants'e-diary."

Trial Locations (7)

Unknown

Site BE32001, Edegem

Site DE49002, Hanover

Site PH63001, Quezon

Site PH63002, Quezon City

Site PL48001, Gdansk

Site TR90002, Ankara

Site TR90001, Mersin

All Listed Sponsors
lead

Astellas Pharma Global Development, Inc.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter