What is Vibegron studying for neurogenic detrusor overactivity in children?

Researchers are evaluating the safety, effectiveness, and how Vibegron is processed by the body in children with neurogenic detrusor overactivity who use clean intermittent catheterization. This study aims to understand Vibegron's impact on bladder function and symptoms over a long-term period. The study is sponsored by Urovant Sciences GmbH.

Who may be eligible for this neurogenic detrusor overactivity clinical trial?

Children aged 2 to 17 years diagnosed with neurogenic detrusor overactivity due to specific neurological conditions and regularly using clean intermittent catheterization may be eligible. Both males and females can participate, but some medical conditions and medications may exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this neurogenic detrusor overactivity clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Phase 3

Age: 2Years - 17Years

All Genders

ID05491525

Long-term Study of Vibegron in Children Ages 2 to Under 18 With Neurogenic Detrusor Overactivity Using Clean Intermittent Catheterization

Led by Urovant Sciences GmbH · Updated on 2026-06-15

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety, effectiveness, and how the body processes Vibegron in children aged 2 to less than 18 years who have neurogenic detrusor overactivity NDO and regularly use clean intermittent catheterization CIC. This open-label trial aims to better understand Vibegrons impact on this pediatric population over a long-term period. Participants receive Vibegron orally once daily, with doses adjusted based on their weight. The study has two parts Part A where doses may be reduced up to two times based on individual responses and safety, and Part B where participants receive a dose selected by a safety monitoring board based on data from Part A. Participants are grouped into cohorts according to weight ranges. Throughout the study, participants undergo assessments including bladder function tests and questionnaires measuring incontinence and symptom severity. Researchers monitor changes in bladder capacity, detrusor activity, catheterized volumes, leakage episodes, and quality of life over approximately 52 weeks. Safety and drug processing are continuously evaluated, with the study expected to complete around September 2030.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 2Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Male or female participants aged 2 to less than 18 years weighing at least 11 kg at screening
Diagnosed with neurogenic detrusor overactivity due to spinal dysraphism, spinal cord injury or surgery (injury/surgery at least 6 months prior), or transverse myelitis diagnosed at least 12 months prior
Using clean intermittent catheterization at least 3 times per 24 hours for at least 4 weeks before screening

You will not qualify if you...

Diagnosis of cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension
Active malignancy within 12 months prior to screening
Received intravesical botulinum toxin within 9 months prior to screening and must remain off during study
Taking digoxin or lithium within 10 days prior to screening or plans to start during study
Current or planned use of baclofen pump during study
Urethral dilatation or surgery within 3 months prior to screening
History of bladder augmentation surgery
Known genitourinary conditions other than NDO causing overactive contractions or incontinence
Insufficient urethral sphincter, artificial sphincter implantation, surgically treated underactive sphincter, or pelvic gender reassignment surgery within 6 months prior to screening
Gastrointestinal problems such as obstruction, decreased motility, risk of gastric retention, or malabsorption syndrome
Acute fecal impaction or hospitalization/surgical treatment for fecal impaction within 3 months prior to screening
Urinary indwelling catheter within 4 weeks prior to screening
Moderate to severe vesicoureteral reflux (Grade IV to V) or severe renal failure
Started electrostimulation/neuromodulation therapy within 4 weeks prior to screening or expected to start during study
Participation in another clinical trial or investigational drug use within 4 weeks prior to screening
Unable or unwilling to washout NDO medications
Females of childbearing potential unwilling or unable to use effective contraception
Female participants currently breastfeeding or planning to breastfeed until 28 days after final study drug administration

Research Team

Study Director

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