RecruitingNeurogenic Detrusor Overactivity

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

Eligible age

2–17 yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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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

Sponsor: Urovant Sciences GmbH

✓ 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.
✕ Participant currently uses or plans to use a baclofen pump during the study.
✕ Participant has had urethral dilatation or urethral surgery in the 3 months prior to the Screening Visit.
✕ Participant has undergone bladder augmentation surgery.
✕ Participant has a known genitourinary condition (other than NDO) that may cause overactive contractions or incontinence (bladder exstrophy, urinary tract obstruction, urethral diverticulum or fistula) or bladder stones or another persistent urinary tract pathology that may cause symptoms.