A Phase 2/3 interventional study of Vibegron in Neurogenic Detrusor Overactivity, sponsored by Urovant Sciences GmbH. Recruiting at 38 sites in 16 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Urovant Sciences GmbH (part of Sumitomo Pharma Co., Ltd.) · Phase 2/3, Interventional, and Treatment
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
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's planned enrollment of 71 is above the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →Urovant Sciences GmbH is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
First submitted after Urovant Sciences GmbH became part of Sumitomo Pharma Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Vibegron
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.
Drug: Vibegron
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.
Drug: Vibegron
Participants will be administered Vibegron orally, once daily (QD)
Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics
Time frame: Optimized Treatment Week 24
Change from Baseline in MCC
Time frame: Optimized Week 12
Change from Baseline in number of overactive detrusor contractions until the end of bladder filling
Time frame: Optimized Treatment Weeks 12 and 24
Change from Baseline in detrusor pressure at the end of bladder filling
Time frame: Optimized Treatment Weeks 12 and 24
Change from Baseline in bladder filling volume until first involuntary/hyperactive detrusor contraction
Time frame: Optimized Treatment Weeks 12 and 24
Change from Baseline in bladder compliance (mL/cm H2O)
Bladder compliance is calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder
Time frame: Optimized Treatment Weeks 12 and 24
Change from Baseline in average first morning catheterized volume
Time frame: through study completion, an average of 52 weeks
Change from Baseline in average catheterized volume per catheterization
Time frame: through study completion, an average of 52 weeks
Change from Baseline in average maximum catheterized volume per day
Time frame: through study completion, an average of 52 weeks
Change from Baseline in average maximum catheterized daytime volume
Time frame: through study completion, an average of 52 weeks
Change from Baseline in average number of leakage episodes per day
Time frame: through study completion, an average of 52 weeks
Change from Baseline in estimated number of dry (leakage-free) days/ 7 days
Time frame: through study completion, an average of 52 weeks
Change from Baseline in Pediatric Incontinence Questionnaire (PIN-Q)
PIN-Q is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicating more impact on the quality of life.
Time frame: through study completion, an average of 52 weeks
Change from Baseline in Patient Global Impression of Severity (PGI-S) Scale
PGI-S is a 5 point scale that determines the bladder condition of a participant with 0 being really bad and 4 as really good. Higher score indicates better bladder condition.
Time frame: through study completion, an average of 52 weeks
Change from Baseline in Clinical Global Impression of Change (CGI-C) Scale
The CGI-C scale is used to determine the degree of change in participant's overall bladder symptoms since the start of the study on Day 1. The scale will be filled by the investigator by ticking on any of the following options: very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse.
Time frame: through study completion, an average of 52 weeks
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Plan to share: Yes — Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.
Access criteria: Access to these clinical trial data can be requested by emailing medinfo@urovant.com and will be provided following Urovant review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).
No publications or documents are linked to this record.
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Studies of the drug tested here: Vibegron