A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC
Part of paid clinical trials in Orange, California.
- Sponsor
- Urovant Sciences GmbH
- Study ID
- NCT05491525
- Phase
- PHASE2/PHASE3
- Status
- Recruiting
Conditions
- Neurogenic Detrusor Overactivity
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Vibegron — DRUGParticipants will be administered Vibegron orally, once daily (QD)
Study Details
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
Key Dates
- Start date
- Oct 12, 2022
- Status verified
- Jul 2024
- Primary completion
- Jan 31, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 85 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1: Vibegron Adolescents (12 to < 18 years)Part A: Participants aged 12 to \< 18 years will receive 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: Vibegron Children (2 to < 12 years)Part A: Participants aged 2 to \< 12 years will receive vibegron based on their weight, after DSMB review of Cohort 1, Part A data, 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.
Primary Outcome Measure
Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics [ Time Frame: Baseline and at Week 32 ]
Central Contacts
- Study Director833-876-8268
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital of Orange County | Orange | California | 92868-4568 | Antoine Khoury (PRINCIPAL_INVESTIGATOR) |
| Nemours Childrens Health, Jacksonville | Jacksonville | Florida | 32207 | Andrew Stec (PRINCIPAL_INVESTIGATOR) |
| Wichita Urology Group | Wichita | Kansas | 67226 | Kahlil N Saad (PRINCIPAL_INVESTIGATOR) |
| Childrens Hospital New Orleans | New Orleans | Louisiana | 70118 | Christopher Roth (PRINCIPAL_INVESTIGATOR) |
| Albany Medical College | Albany | New York | 12208 | Alexandra Rehfuss (PRINCIPAL_INVESTIGATOR) |
| Duke University Medical Center | Durham | North Carolina | 27710 | John S. Wiener (PRINCIPAL_INVESTIGATOR) |