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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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Access to anonymized individual participant level data will not be provided for this trial.  Further details on Astellas’ data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Participants will receive mirabegron prolonged-release microgranula-based oral suspension.

People with neurogenic detrusor overactivity (NDO) have poor bladder control because of how their nerves to the bladder are wired.  This can cause high pressure in the bladder, causing it to leak urine by accident (incontinence).  Mirabegron has already been approved for adults with bladder problems and for children 3 years and older.  This study will learn if mirabegron can help young children with NDO.  The children will be from 6 months to up to 3 years old.  

The main aim of this study is to learn if mirabegron increases how much urine the bladder holds (maximum cystometric capacity, or Maximum Cystometric Capacity [MCC]) in young children with NDO.  An increase in MCC will prevent high pressure in the bladder.

Children from 6 months to up to 3 years old who have NDO can take part.  They must weigh 9 kilograms (kg) or more.  They will already be fitted with a tube (catheter) in their bladder.  They will use this to drain urine from their bladder regularly during the day.  This is called clean intermittent catheterization (CIC).

There will be 2 groups in the study.  Young children who aren’t taking certain medicines for NDO will be in group A.  Young children who are taking certain medicines for NDO will be in group B.  Children in group B will stop taking these medicines before they start taking mirabegron.  Treatment in group B will be delayed to allow the medicines to be cleared from the body before they start taking mirabegron.  Both groups (A and B) will have the same treatment and dose of mirabegron and will have the same checks throughout the study.

Mirabegron will be squirted from a syringe into the children’s mouths, followed by a sip of water.  This will happen once a day for up to 52 weeks (1 year).  They will start on a low dose, adjusted for their weight.  The dose may be increased to a higher dose if the study doctor thinks the child will benefit from the higher dose.  

Children will have safety checks throughout the study.  Other tests will include checking how the bladder fills and empties plus an ultrasound of the bladder area. 

There will be several clinic visits during the study.  There will be fewer clinic visits if a child stays on the low dose of mirabegron.  Then, the clinic will phone the caregiver about 1 month after the last dose of mirabegron to check if there are any further medical problems.

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

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

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.

Site TR90001

Site PH63002

Site BE32001

Site DK45001

Site PH63001

Site TR90002

Site PL48001

Stanford Hospital

Site DE49003

Intermountain Primary Children

Nemours Children's Clinic

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

MCC is maximum bladder capacity reached at end of filling cytometry.

Bladder compliance is calculated by change in volume divided by change in pressure during filling of the bladder.

Change in bladder volume calculated by urodynamic assessments.

Change in number of of uninhibited detrusor contractions is calculated by urodynamic assessments.

E-diary measure based on first catheterization after participant wakes up.

Based on participant e-diary, dry defined as leakage-free.

The P-OMAQ-C uses a 5-point numerical rate scale to measure acceptability of use of the tablet formulation with questions related to taste, smell and administration of study medication. Acceptability questionnaires to be completed by caregivers on an electronic device.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator and events related to the (study) procedures.

Number of participants with potentially clinically significant vital sign values.

Number of participants with potentially clinically significant laboratory values.

Number of participants with potentially clinically significant ECG values.

Number of participants with potentially clinically significant upper urinary tract ultrasounds.

AUC24 will be recorded from the PK plasma samples collected.

Ctrough will be recorded from the PK plasma samples collected.

CL/F will be recorded from the PK plasma samples collected.

VzF will be recorded from the PK plasma samples collected.

Cmax will be recorded from the PK plasma samples collected.

Tmax will be recorded from the PK plasma samples collected.