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

Recruiting Phase 2 Phase 3 Interventional Study
Neurogenic Detrusor Overactivity
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
71 (estimated)
Sponsor
Urovant Sciences GmbH · Industry
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About This Trial

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

Trial Locations
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Eligibility Criteria
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 o…
Contacts

Study Director

833-876-8268

clinicaltrials@us.sumitomo-pharma.com

CONTACT