Vibegron for Neurogenic Detrusor Overactivity in Children
This study is looking at the long-term safety and effectiveness of Vibegron in children aged 2 to under 18 years old. These children have neurogenic detrusor overactivity (NDO), a bladder condition often linked to spinal cord issues, and are already using clean intermittent catheterization (CIC). Participants will take Vibegron by mouth once a day. The main goal is to see how much Vibegron changes the maximum amount of urine the bladder can hold (maximum cystometric capacity or MCC) after 24 weeks of optimized treatment. The study plans to enroll 71 participants. The current recruitment status is unclear.
- Study design
- This is an open-label study, meaning both you and the study team will know you are receiving Vibegron. It plans to include 71 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at Optimized Treatment Week 24, suggesting follow-up for at least this duration.
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NCT05491525
Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
Recruiting
PHASE2Ages 2–17InterventionalTreatmentUrovant Sciences GmbH
~71 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Vibegron
At a glance
Recruiting sites
32 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics
Measured over Optimized Treatment Week 24
Conditions
Where it's being run
38 sites across 29 statesJordan3
Poland3
New York2
Lithuania2
Bucharest2
Serbia2
Slovakia2
Arkansas1
Study leadership
- Janet Owens-Grillo · STUDY_DIRECTOR · Sumitomo Pharma America
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Male or female participants, age 2 years to \< 18 years and weighing at least 11 kg at the Screening Visit.
Participant has been diagnosed with NDO due to one of the following: spinal dysraphism, which includes spina bifida (eg, myelomeningocele, meningocele) and all forms of tethered cord; or acquired NDO from a spinal cord injury or spinal cord surgery, with the injury/surgery having occurred at least 6 months prior to the Screening Visit; or acquired NDO due to transverse myelitis with diagnosis at least 12 months prior to the Screening Visit.
Participant undergoes CIC at least 3 times per 24 hours (with the last CIC performed prior to going to sleep for the night) for at least 4 weeks prior to the Screening Visit.
Exclusion
Participant has cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension
Participant has an active malignancy in the 12 months prior to the Screening Visit.
Participant has been administered intravesical botulinum toxin within 9 months prior to the Screening Visit and should remain off this therapy during the study.
Participant is taking digoxin or lithium within 10 days prior to Screening Visit or plans to start taking either during the study.
Participant currently uses or plans to use a baclofen pump during the study.
Participant has had urethral dilatation or urethral surgery in the 3 months prior to the Screening Visit.
Participant has undergone bladder augmentation surgery.
Participant has a known genitourinary condition (other than NDO) that may cause overactive contractions or incontinence (bladder exstrophy, urinary tract obstruction, urethral diverticulum or fistula) or bladder stones or another persistent urinary tract pathology that may cause symptoms.
Participant has an insufficient urethral sphincter, has had implantation of an artificial sphincter, has a surgically-treated underactive urethral sphincter, or, in the 6 months prior to the Screening Visit, has undergone pelvic gender reassignment surgery.
Participant has one of the following gastrointestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, risk of gastric retention, or malabsorption syndrome of any form.
Participant has acute fecal impaction or, within the 3 months prior to the Screening Visit, had fecal impaction that required hospitalization or ambulatory surgical treatment.
Participant had a urinary indwelling catheter in the 4 weeks prior to the Screening Visit.
Participant has moderate to severe dilating vesicoureteral reflux (Grade IV to V) or severe renal failure.
Participant started electrostimulation/neuromodulation therapy in the 4 weeks before the Screening Visit, or is expected to start this therapy during the study period.
Participant has participated in another clinical trial and/or has taken an investigational drug within 4 weeks prior to the Screening Visit.
Participant is unable, or parent/caregiver is not willing, to washout any medication for the management of NDO.
Participant is a female of childbearing potential who is unwilling or unable to use a highly effective method of contraception for the duration of the study.
Female participants who are currently breastfeeding or plan to breastfeed any time from the Screening Visit until 28 days after the final study drug administration.
What this trial measures
- Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamicsOptimized Treatment Week 24