Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05621616
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2022-11-11
Brief Title:
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
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 6 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 arent 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 childrens 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
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 6 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 arent 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 childrens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-005455-37 | EUDRACT_NUMBER | None | None |