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Beta-3 Adrenergic Agonist
Mirabegron for Overactive Bladder in Children
Phase 3
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 4, 24 and 52
Awards & highlights
Study Summary
This trial is studying whether a medicine, mirabegron, can help young children (6m-3yrs) with poor bladder control due to neurogenic detrusor overactivity. It will look at how it affects their maximum bladder capacity and if there are any side effects.
Who is the study for?
This trial is for young children aged 6 months to under 3 years with neurogenic detrusor overactivity, a condition affecting bladder control. They must weigh at least 6 kg, use clean intermittent catheterization, and be able to swallow the medication. The child's caregiver must agree to follow study procedures and not enroll the child in another interventional study during this one.Check my eligibility
What is being tested?
The trial is testing mirabegron, a medicine approved for adults with bladder issues, on young children with poor bladder control due to nerve problems. It aims to see if it can increase maximum bladder capacity after 24 weeks of treatment. Children will take mirabegron daily for up to 52 weeks starting at a low dose that may be increased based on doctor's assessment.See study design
What are the potential side effects?
Possible side effects of mirabegron include increased blood pressure and heart rate which will be monitored regularly through vital signs checks and ECGs. Caregivers will also record any other medical problems or symptoms experienced by their child throughout the treatment period.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and weeks 4, 24 and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 4, 24 and 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
Secondary outcome measures
Acceptability by pediatric oral medicine acceptability questionnaire for caregivers (P-OMAQ-C)
Change from baseline in average catheterized daytime volume
Change from baseline in average morning catheterized volume
+17 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: mirabegronExperimental Treatment1 Intervention
Participants will receive mirabegron prolonged-release microgranula-based oral suspension.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mirabegron
2018
Completed Phase 4
~9230
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
121,052 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,063,854 Total Patients Enrolled
2 Trials studying Neurogenic Detrusor Overactivity
32 Patients Enrolled for Neurogenic Detrusor Overactivity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before the first screening visit.I am either malnourished or severely overweight.I currently have a urinary tract infection confirmed by a urine test.I have a severe stomach or intestine condition.I have a bladder condition causing frequent urination or leakage.I can swallow pills.I have a severe form of urinary reflux.I am undergoing or will start electrostimulation therapy soon.I am not taking any medications that are not allowed in the study.I have had surgery to make my bladder larger.I have been diagnosed with a specific type of diabetes that affects my kidneys.I have severe kidney problems.I can manage 4 to 6 daily treatments for the study's duration.I have a history of epilepsy.I had surgery to fix a weak bladder control muscle.I had bladder botox over 4 months ago and my symptoms are back.I weigh at least 6 kg.I have been diagnosed with NDO based on a bladder function test.I have high blood pressure that is above the normal range for my age, gender, and body size.I have been diagnosed with detrusor sphincter dyssynergia.
Research Study Groups:
This trial has the following groups:- Group 1: mirabegron
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial accept applications from octogenarians?
"Qualified applicants for this medical trial must be between 6 months and 3 years old. In addition, there are 7 trials available to individuals younger than 18 while 60 additional studies are open to people aged 65 or over."
Answered by AI
Has mirabegron obtained its stamp of approval from the FDA?
"We believe that mirabegron is a safe drug and gave it a 3 rating due to the evidence from efficacy trials and numerous safety assessments conducted within Phase 3."
Answered by AI
Are there any opportunities to sign up for the investigation currently?
"According to clinicaltrials.gov, this trial has paused its patient recruitment efforts. Initially posted on November 30th 2022 and last updated on the 11th of November that same year, no further candidates need be sourced for now; however, 67 other studies are still actively looking for participants."
Answered by AI
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