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
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.
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.
Parallel
Vibegron
DrugParticipants will be administered Vibegron orally, once daily (QD)
Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics
Change from Baseline in MCC
Change from Baseline in number of overactive detrusor contractions until the end of bladder filling
Change from Baseline in detrusor pressure at the end of bladder filling
Change from Baseline in bladder filling volume until first involuntary/hyperactive detrusor contraction
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Urovant Sciences GmbH
Lead sponsor
Sumitomo Pharma America, Inc.
Collaborator