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NCT05491525PHASE2, PHASE3Recruiting

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

Urovant Sciences GmbH

Start Date

10/12/2022

Completion Date

9/1/2030

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

Eligibility Criteria

Age Range: 2 years to 17 years

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.

Interventions

DRUG

Vibegron

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Conditions

Neurogenic Detrusor Overactivity

Locations

Arkansas Childrens Hospital

Little Rock, Arkansas 72202

United States

Children's Hospital of Orange County

Orange, California 92868-4568

United States

Children's Hospital Colorado

Aurora, Colorado 800045

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

SUNY Upstate Medical University

Syracuse, New York 13210

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

University of Oklahoma

Oklahoma City, Oklahoma 73104

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen 2650

Belgium

UZ Gent

Ghent, East Flanders 9000

Belgium

Alberta Children's Hospital

Calgary, Alberta T3B 6A8

Canada

The Hospital for Sick Children

Toronto, Ontario M5G 1E8

Canada

University Hospital Split - KBC Split

Split, 21000

Croatia

Aarhus University Hospital - Department of Paediatrics and Adolescent Medicine

Aarhus, 8200

Denmark

JSC Evex Hospital M. lashvili Childrens Central Hospital

Tbilisi, 0159

Georgia

Istiklal Hospital

Amman, 11821

Jordan

Jordan University Hospital

Amman, 11942

Jordan

Irbid Specialty Hospital

Irbid, 21110

Jordan

Childrens Clinical University Hospital

Riga, LV-1004

Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, LT-50161

Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, LT-08406

Lithuania

Kuala Lumpur Hospital

Kuala Lumpur, Kuala Lumpur 50586

Malaysia

Hospital Umum Sarawak

Kuching, Sarawak 93586

Malaysia

National Children's Hospital

Quezon City, National Capital Region 1102

Philippines

Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

Bialystok, 15-274

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952

Poland

Instytut Pomnik - Centrum Zdrowia Dziecka

Warsaw, 04-736

Poland

Institutul Clinic Fundeni

Bucharest, Bucharest 22328

Romania

Maria Sklodowska Curie Childrens Clinical Emergency Hospital

Bucharest, Bucharest 41451

Romania

University Children's Hospital Tirsova

Belgrade, 11000

Serbia

Children and Youth Health Care Institute of Vojvodina

Novi Sad, 21000

Serbia

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

Bratislava, 83301

Slovakia

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

Bratislava, 85101

Slovakia

Ankara University Faculty of Medicine Ibni Sina Hospital

Ankara, Altindag 6230

Turkey (Türkiye)

Mersin University, Dept. of Urology

Yenişehir, 33343

Turkey (Türkiye)