RECRUITING

A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 2/3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)

Quick Facts

Study Start:2022-10-12

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05491525

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Male or female participants, age 2 years to \< 18 years at the Screening Visit. Participants age 12 to \< 18 years (Cohort 1) must weigh at least 29.5 kilograms (kg). Participants age 2 to \< 12 years (Cohort 2) must weigh at least 11 kg. * 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.	* 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 urethral dilatation or has had 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 fecal impaction or a history of fecal impaction requiring hospitalization or ambulatory surgical treatment in the 3 months prior to the Screening Visit. * Participant has a urinary indwelling catheter in the 4 weeks prior to the Screening Visit. * Participant has moderate to severe dilating vesicoureteral reflux (Grade III 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.

Inclusion Criteria

Exclusion Criteria

* Male or female participants, age 2 years to \< 18 years at the Screening Visit. Participants age 12 to \< 18 years (Cohort 1) must weigh at least 29.5 kilograms (kg). Participants age 2 to \< 12 years (Cohort 2) must weigh at least 11 kg.
* 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.

* 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 urethral dilatation or has had 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 fecal impaction or a history of fecal impaction requiring hospitalization or ambulatory surgical treatment in the 3 months prior to the Screening Visit.
* Participant has a urinary indwelling catheter in the 4 weeks prior to the Screening Visit.
* Participant has moderate to severe dilating vesicoureteral reflux (Grade III 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.

Contacts and Locations

Study Contact

Study Director

CONTACT

833-876-8268

clinicaltrials@urovant.com

Study Locations (Sites)

Children's Hospital of Orange County

Orange, California, 92868-4568

United States

Nemours Childrens Health, Jacksonville

Jacksonville, Florida, 32207

United States

Wichita Urology Group

Wichita, Kansas, 67226

United States

Childrens Hospital New Orleans

New Orleans, Louisiana, 70118

United States

Albany Medical College

Albany, New York, 12208

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Urovant Sciences GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-12

Study Completion Date2027-09

Study Record Updates

Study Start Date2022-10-12

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Neurogenic Detrusor Overactivity