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)
Urovant Sciences GmbH
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
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female participants, age 2 years to \< 18 years at the Screening Visit. Participants age 12 to \< 18 years (Cohort 1) must weigh at least 29.5 kilograms (kg). Participants age 2 to \< 12 years (Cohort 2) must weigh at least 11 kg. * 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…
Interventions
- DrugVibegron
Participants will be administered Vibegron orally, once daily (QD)
Locations (6)
- Children's Hospital of Orange CountyOrange, California
- Nemours Childrens Health, JacksonvilleJacksonville, Florida
- Wichita Urology GroupWichita, Kansas
- Childrens Hospital New OrleansNew Orleans, Louisiana
- Albany Medical CollegeAlbany, New York
- Duke University Medical CenterDurham, North Carolina