Trials / Recruiting
RecruitingNCT05491525
A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC
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)
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- Sponsor
- Urovant Sciences GmbH · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vibegron | Participants will be administered Vibegron orally, once daily (QD) |
Timeline
- Start date
- 2022-10-12
- Primary completion
- 2027-01-01
- Completion
- 2027-09-01
- First posted
- 2022-08-08
- Last updated
- 2024-07-03
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05491525. Inclusion in this directory is not an endorsement.