Recruiting

Phase 2

Phase 3

VibegronOpen-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

Sponsor:

Urovant Sciences GmbH

Code:

NCT05491525

Conditions

Neurogenic Detrusor Overactivity

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Vibegron

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC

Conditions

Neurogenic Detrusor Overactivity

Study ID

NCT05491525

Start date

Oct 12, 2022

Status verified date

Jun, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

71 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Weight >=41.5kg

Part A: Participants will receive a dose of Vibegron based on their weight, with dose reduction based on individual clinical condition, PK, and safety/tolerability data. Participants may be dose-reduced up to 2 times.

Part B: Participants will receive a Data and Safety Monitoring Board (DSMB)-selected Vibegron dose for their weight determined from participants in their respective cohort and weight band of Part A.

experimental: Cohort 2: Weight Range >=29.5 kg to <=41.4 kg

Part A: participants will receive a dose of Vibegron based on their weight, with dose reduction based on individual clinical condition, PK, and safety/tolerability data. Participants may be dose-reduced up to 2 times.

Part B: Participants will receive a DSMB-selected Vibegron dose for their weight determined from participants in their respective cohort and weight band of Part A.

experimental: Cohort 3: Weight range >=11 kg to <=29.4 kg

Part A: Participants will receive a dose of Vibegron based on their weight, with dose reduction based on individual clinical condition, PK, and safety/tolerability data. Participants may be dose-reduced up to 2 times.

Part B: Participants will receive a DSMB-selected Vibegron dose for their weight determined from participants in their respective cohort and weight band of Part A.

Interventions

Vibegron

Participants will be administered Vibegron orally, once daily (QD)

Primary outcome measure

Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics [ Time Frame: Optimized Treatment Week 24 ]

Central Contacts and Locations

Central contacts

Study Director

833-876-8268 clinicaltrials@us.sumitomo-pharma.com

Locations

Arkansas Childrens Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Principal Investigator:

Ashay Patel

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 800045

Principal Investigator:

Kyle Rove

Nemours Childrens Health, Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Principal Investigator:

Andrew Stec

Wichita Urology Group

Recruiting

Wichita, Kansas, United States, 67226

Principal Investigator:

Kahlil N Saad

Albany Medical College

Recruiting

Albany, New York, United States, 12208

Principal Investigator:

Alexandra Rehfuss

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Principal Investigator:

Jeffery Villanueva

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Principal Investigator:

Dominic Frimberger

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Principal Investigator:

Bryce Weber

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1E8

Principal Investigator:

Michael Chua

More Information

Sponsor

Urovant Sciences GmbH

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

Neurogenic Detrusor Overactivity
Vibegron
Clean Intermittent Catheterization
Beta-3 Adrenergic Receptor Agonist
Maximum Cystometric Capacity
Spinal Dysraphism
Spina Bifida
Myelomeningocele
Meningocele
Spinal cord injury
Transverse myelitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Urovant Sciences GmbH on 2026-06-15.