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

ملخص

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

الأهلية

تصميم الدراسة

مقاييس النتائج

1. مقياس النتيجة الأولي

   Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics

   الإطار الزمني Optimized Treatment Week 24

2. مقياس النتيجة الثانوي

   Change from Baseline in MCC

   الإطار الزمني Optimized Week 12

3. مقياس النتيجة الثانوي

   Change from Baseline in number of overactive detrusor contractions until the end of bladder filling

   الإطار الزمني Optimized Treatment Weeks 12 and 24

4. مقياس النتيجة الثانوي

   Change from Baseline in detrusor pressure at the end of bladder filling

   الإطار الزمني Optimized Treatment Weeks 12 and 24

5. مقياس النتيجة الثانوي

   Change from Baseline in bladder filling volume until first involuntary/hyperactive detrusor contraction

   الإطار الزمني Optimized Treatment Weeks 12 and 24

6. مقياس النتيجة الثانوي

   Change from Baseline in bladder compliance (mL/cm H2O)

   Bladder compliance is calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder

   الإطار الزمني Optimized Treatment Weeks 12 and 24

7. مقياس النتيجة الثانوي

   Change from Baseline in average first morning catheterized volume

   الإطار الزمني through study completion, an average of 52 weeks

8. مقياس النتيجة الثانوي

   Change from Baseline in average catheterized volume per catheterization

   الإطار الزمني through study completion, an average of 52 weeks

9. مقياس النتيجة الثانوي

   Change from Baseline in average maximum catheterized volume per day

   الإطار الزمني through study completion, an average of 52 weeks

10. مقياس النتيجة الثانوي

    Change from Baseline in average maximum catheterized daytime volume

    الإطار الزمني through study completion, an average of 52 weeks

11. مقياس النتيجة الثانوي

    Change from Baseline in average number of leakage episodes per day

    الإطار الزمني through study completion, an average of 52 weeks

12. مقياس النتيجة الثانوي

    Change from Baseline in estimated number of dry (leakage-free) days/ 7 days

    الإطار الزمني through study completion, an average of 52 weeks

13. مقياس النتيجة الثانوي

    Change from Baseline in Pediatric Incontinence Questionnaire (PIN-Q)

    PIN-Q is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicating more impact on the quality of life.

    الإطار الزمني through study completion, an average of 52 weeks

14. مقياس النتيجة الثانوي

    Change from Baseline in Patient Global Impression of Severity (PGI-S) Scale

    PGI-S is a 5 point scale that determines the bladder condition of a participant with 0 being really bad and 4 as really good. Higher score indicates better bladder condition.

    الإطار الزمني through study completion, an average of 52 weeks

15. مقياس النتيجة الثانوي

    Change from Baseline in Clinical Global Impression of Change (CGI-C) Scale

    The CGI-C scale is used to determine the degree of change in participant's overall bladder symptoms since the start of the study on Day 1. The scale will be filled by the investigator by ticking on any of the following options: very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse.

    الإطار الزمني through study completion, an average of 52 weeks

التواريخ

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

32 موقعاً قيد التجنيد

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.