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Neurogenic Detrusor OveractivityPhase 2/3KANGUROONCT05491525

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

A Phase 2/3 study testing Vibegron in people with Neurogenic Detrusor Overactivity, run by Urovant Sciences GmbH at 38 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Neurogenic Detrusor Overactivity
What is being tested?
Vibegron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
38 sitesin 16 countries
Study dates
12 Oct 2022to Sep 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

38 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

833-876-8268

clinicaltrials@us.sumitomo-pharma.com

38 sites in 16 countries

United States11 sites, 7 recruiting

  • Albany Medical College

    Albany, New York, 12208

    Alexandra Rehfuss

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 800045

    Kyle Rove

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Terminated

  • Nemours Childrens Health, Jacksonville

    Jacksonville, Florida, 32207

    Andrew Stec

    Recruiting

  • Arkansas Childrens Hospital

    Little Rock, Arkansas, 72202

    Ashay Patel

    Recruiting

  • Childrens Hospital New Orleans

    New Orleans, Louisiana, 70118

    Withdrawn

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

    Dominic Frimberger

    Recruiting

  • Children's Hospital of Orange County

    Orange, California, 92868-4568

    Terminated

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Withdrawn

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

    Jeffery Villanueva

    Recruiting

  • Wichita Urology Group

    Wichita, Kansas, 67226

    Kahlil N Saad

    Recruiting

Other trials in United States

Jordan3 sites, 3 recruiting

  • Istiklal Hospital

    Amman, 11821

    Mohammad Al-Zubi

    Recruiting

  • Jordan University Hospital

    Amman, 11942

    Raed Altaher

    Recruiting

  • Irbid Specialty Hospital

    Irbid, 21110

    Osama Bani-Hani

    Recruiting

Other trials in Jordan

Poland3 sites, 3 recruiting

  • Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

    Bialystok, 15-274

    Anna Wasilewska

    Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

    Michal Maternik

    Recruiting

  • Instytut Pomnik - Centrum Zdrowia Dziecka

    Warsaw, 04-736

    Piotr Gastol

    Recruiting

Other trials in Poland

Belgium2 sites, 1 recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, Antwerpen, 2650

    Withdrawn

  • UZ Gent

    Ghent, East Flanders, 9000

    Erik Van Laecke

    Recruiting

Other trials in Belgium

Canada2 sites, 2 recruiting

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

    Bryce Weber

    Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1E8

    Michael Chua

    Recruiting

Other trials in Canada

Lithuania2 sites, 2 recruiting

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, LT-50161

    Sarunas Rudaitis

    Recruiting

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08406

    Beata Vincel

    Recruiting

Other trials in Lithuania

Malaysia2 sites, 2 recruiting

  • Kuala Lumpur Hospital

    Kuala Lumpur, Kuala Lumpur, 50586

    Poongkodi Nagappan

    Recruiting

  • Hospital Umum Sarawak

    Kuching, Sarawak, 93586

    Ing Soon Ngu

    Recruiting

Other trials in Malaysia

Romania2 sites, 2 recruiting

  • Institutul Clinic Fundeni

    Bucharest, Bucharest, 22328

    Robert Stoica

    Recruiting

  • Maria Sklodowska Curie Childrens Clinical Emergency Hospital

    Bucharest, Bucharest, 41451

    Beatrice Bunea

    Recruiting

Other trials in Romania

Serbia2 sites, 2 recruiting

  • University Children's Hospital Tirsova

    Belgrade, 11000

    Dusan Parapovic

    Recruiting

  • Children and Youth Health Care Institute of Vojvodina

    Novi Sad, 21000

    Dragan Sarac

    Recruiting

Other trials in Serbia

Slovakia2 sites, 2 recruiting

  • Detská fakultná nemocnica s poliklinikou/Národný ústav detských chorôb (NÚDCH)

    Bratislava, 83301

    Peter Barton

    Recruiting

  • Urologická ambulancia J. BREZA MEDICAL s.r.o.

    Bratislava, 85101

    Jan Breza

    Recruiting

Other trials in Slovakia

Turkey (Türkiye)2 sites, 2 recruiting

  • Ankara University Faculty of Medicine Ibni Sina Hospital

    Ankara, Altindag, 6230

    Berk Burgu

    Recruiting

  • Mersin University, Dept. of Urology

    Yenişehir, 33343

    Erim Erdem

    Recruiting

Other trials in Turkey (Türkiye)

Croatia1 site, 1 recruiting

  • University Hospital Split - KBC Split

    Split, 21000

    Tanja Kovacevic

    Recruiting

Other trials in Croatia

Denmark1 site, 1 recruiting

  • Aarhus University Hospital - Department of Paediatrics and Adolescent Medicine

    Aarhus, 8200

    Kostas Kamperis

    Recruiting

Other trials in Denmark

Georgia1 site, 1 recruiting

  • JSC Evex Hospital M. lashvili Childrens Central Hospital

    Tbilisi, 0159

    Tinatin Davitaia

    Recruiting

Other trials in Georgia

Latvia1 site

  • Childrens Clinical University Hospital

    Riga, LV-1004

    Withdrawn

Other trials in Latvia

Philippines1 site, 1 recruiting

  • National Children's Hospital

    Quezon City, National Capital Region, 1102

    Carlo Bisnar

    Recruiting

Other trials in Philippines

About this study

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)

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

Being tested
Vibegron
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
Medical subject headings
Spinal Dysraphism, Meningomyelocele, Meningocele, Spinal Cord Injuries, Myelitis, Transverse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VibegronDrug

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

Study groups in NCT05491525
Study groupRoleWhat they receive
Cohort 1: Weight >=41.5kgExperimentalPart 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.
Receives: Drug: Vibegron
Cohort 2: Weight Range >=29.5 kg to <=41.4 kgExperimentalPart 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.
Receives: Drug: Vibegron
Cohort 3: Weight range >=11 kg to <=29.4 kgExperimentalPart 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.
Receives: Drug: Vibegron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics

    Measured: Optimized Treatment Week 24

Secondary outcomes (14)

  1. Change from Baseline in MCC

    Measured: Optimized Week 12

  2. Change from Baseline in number of overactive detrusor contractions until the end of bladder filling

    Measured: Optimized Treatment Weeks 12 and 24

  3. Change from Baseline in detrusor pressure at the end of bladder filling

    Measured: Optimized Treatment Weeks 12 and 24

  4. Change from Baseline in bladder filling volume until first involuntary/hyperactive detrusor contraction

    Measured: Optimized Treatment Weeks 12 and 24

  5. 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

    Measured: Optimized Treatment Weeks 12 and 24

  6. Change from Baseline in average first morning catheterized volume

    Measured: through study completion, an average of 52 weeks

  7. Change from Baseline in average catheterized volume per catheterization

    Measured: through study completion, an average of 52 weeks

  8. Change from Baseline in average maximum catheterized volume per day

    Measured: through study completion, an average of 52 weeks

  9. Change from Baseline in average maximum catheterized daytime volume

    Measured: through study completion, an average of 52 weeks

  10. Change from Baseline in average number of leakage episodes per day

    Measured: through study completion, an average of 52 weeks

  11. Change from Baseline in estimated number of dry (leakage-free) days/ 7 days

    Measured: through study completion, an average of 52 weeks

  12. 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.

    Measured: through study completion, an average of 52 weeks

  13. 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.

    Measured: through study completion, an average of 52 weeks

  14. 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.

    Measured: through study completion, an average of 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2022
  2. Study start12 Oct 2022
  3. Primary completionMar 2030 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05491525
Sponsor's protocol ID
URO-901-3007
Acronym
KANGUROO
Status last verified
Jun 2026
First submitted
28 Jul 2022
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Vibegron in people with Neurogenic Detrusor Overactivity, run by Urovant Sciences GmbH at 38 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Jordan, Poland, Belgium, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (833-876-8268, clinicaltrials@us.sumitomo-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics (time frame: Optimized Treatment Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05491525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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