A Study of Mirabegron in Young Children With Neurogenic Detrusor Overactivity
Status:
Not yet recruiting
Trial end date:
2025-08-31
Target enrollment:
Participant gender:
Summary
People with neurogenic detrusor overactivity have poor bladder control because of how their
nerves to the bladder are wired. This can cause high pressure in the bladder. It can also
cause the bladder to leak by accident (incontinence).
In this study, the researchers are studying whether a medicine, mirabegron, can help young
children with neurogenic detrusor overactivity. The children will be from 6 months to under 3
years old. Mirabegron has already been approved for adults with bladder problems. The main
aim of this study is to learn if mirabegron increases the maximum bladder capacity (to
prevent high pressure in the bladder) in young children after 24 weeks of treatment. Maximum
bladder capacity is the maximum amount of urine that the bladder can hold before it releases
urine or starts to leak.
There will be 2 groups in the study. Young children who are not taking certain medicines for
their condition will be in group A. Young children who are already taking certain medicines
for this condition will be in group B. Children in group B will stop taking these medicines
before taking mirabegron. Their treatment will be delayed by 2 weeks to allow the other
medicines to be cleared from the body before treatment. Both groups (A and B) will take the
same treatment and have the same checks throughout the study.
Children will have their vital signs checked (blood pressure, heart rate and body
temperature). They will also have an ECG to check their heart rhythm and give urine samples
for laboratory tests. Other tests will include checking how the bladder fills and empties
plus an ultrasound of the bladder area. The caregivers will be shown how to check their
child's blood pressure. They will be given an electronic diary to record the blood pressure,
as well as any other medicines taken. They will do this every day for 7 days before each
visit.
Mirabegron will be stirred into water, making it easier for children to drink. Children will
drink mirabegron once a day for up to 52 weeks. They will start on a low dose, adjusted for
their weight. If children are taking other medicines for this condition, they will wait an
extra 2 weeks before starting mirabegron. At weeks 2, 4 and 8, the dose may be increased once
to a higher dose if the study doctor thinks the child will benefit from the higher dose. The
children and their caregivers will visit the clinic at 2, 4, 8, 12, 24, 52, and 54 weeks.
There will be fewer clinic visits if a child stays on the lower dose of mirabegron. In this
case, the clinic will phone the caregiver instead to check the information in the diary.
During each visit, the children will have their vital signs checked and have an ECG. The
caregiver will be asked if their child has had any medical problems. At some visits, the
children will give urine and blood samples for laboratory tests. Other tests will include
checking how the bladder fills and empties.
36 weeks after treatment starts, the clinic will phone the caregiver to ask if their child
has had any medical problems, and will check the information in the diary. The children and
their caregivers will visit the clinic 52 weeks after treatment starts. The caregiver will be
asked if their child has had any medical problems. The children will have a physical exam and
have their vital signs checked. Also, they will have an ECG and have urine and blood samples
taken for laboratory tests. Other tests will include an ultrasound of the bladder area.
There will be a final clinic visit at 54 weeks. The caregiver will be asked if their child
has had any medical problems. The children will have a physical exam and will have their
vital signs checked. They will also have an ECG.
The caregiver will be asked to complete a survey on their child's experience with taking
mirabegron. They will do this at 4, 24 and 52 weeks after their child starts treatment.
Finally, the clinic will phone the caregiver 30 days after the last dose of mirabegron to
check if there were any further medical problems.
No other visits are planned during this study.