Study on the Safety and Effectiveness of Vibegron for Children Aged 2 to 17 with Neurogenic Bladder Overactivity Using Clean Intermittent Catheterization

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What is this study about?

This clinical trial is focused on studying a condition called Neurogenic Detrusor Overactivity (NDO), which affects the bladder’s ability to store urine properly. The study involves children and teenagers aged 2 to under 18 years who use a method called Clean Intermittent Catheterization (CIC) to help empty their bladders. The treatment being tested is a medication called Vibegron, which is taken orally in the form of granules or film-coated tablets. The purpose of the study is to evaluate the safety and effectiveness of Vibegron in managing NDO symptoms in young patients.

Participants in the study will receive Vibegron over a period of up to 52 weeks. During this time, they will have regular check-ups to monitor their health and the effects of the medication. The study will also involve assessments to understand how the body processes the medication, known as pharmacokinetics. This includes measuring how much of the drug is in the blood at different times and how long it stays in the body.

The study aims to see if Vibegron can help improve bladder function and reduce symptoms associated with NDO. Participants will be observed for changes in bladder activity and any side effects they might experience. The study will also look at how the treatment affects the participants’ quality of life over time. This research is important for finding better ways to manage NDO in children and teenagers, potentially leading to improved treatments in the future.

1 joining the study

Upon joining the study, participants are assigned to one of two groups based on age and weight. Participants aged 12 to less than 18 years must weigh at least 29.5 kilograms, while those aged 2 to less than 12 years must weigh at least 11 kilograms.

Participants must have been diagnosed with neurogenic detrusor overactivity (NDO) due to specific conditions such as spinal dysraphism or acquired NDO from spinal cord injury or surgery.

2 medication administration

Participants will receive the medication vibegron, which is administered orally. The form of the medication may be granules or film-coated tablets.

The medication is taken once daily (QD), and the dosage is determined based on the participant’s age and weight.

3 treatment duration

The study is designed to evaluate the long-term effects of the medication, with assessments occurring at various intervals throughout the study period.

The primary endpoint is assessed at Study Week 32, while secondary endpoints are evaluated at multiple points, including Study Weeks 1, 4, 8, 20, 32, 48, and 52.

4 assessments and evaluations

Participants will undergo regular assessments to monitor the efficacy and safety of the medication. These include urodynamic studies, bladder diaries, and questionnaires.

Safety evaluations include monitoring for adverse events, conducting ultrasounds of the upper urinary tract, and measuring vital signs such as pulse rate and blood pressure.

5 study completion

The study is expected to conclude by March 31, 2029. Participants will have contributed valuable data to understand the long-term effects of vibegron in treating NDO in pediatric subjects.

Who Can Join the Study?

Participants must be male or female and between 2 years to less than 18 years old at the time of the Screening Visit.
Participants aged 12 to less than 18 years must weigh at least 29.5 kilograms (kg).
Participants aged 2 to less than 12 years must weigh at least 11 kg.
Participants must have been diagnosed with Neurogenic Detrusor Overactivity (NDO). This condition can be due to:
- Spinal dysraphism, which includes conditions like spina bifida (such as myelomeningocele or meningocele) and all forms of tethered cord.
- Acquired NDO from a spinal cord injury or spinal cord surgery, with the injury or surgery having occurred at least 6 months before the Screening Visit.
- Acquired NDO due to transverse myelitis, with the diagnosis made at least 12 months before the Screening Visit.
Participants must perform Clean Intermittent Catheterization (CIC) at least 3 times every 24 hours (with the last CIC done before going to sleep) for at least 4 weeks before the Screening Visit. CIC is a procedure where a thin tube is used to empty the bladder.

Who Cannot Join the Study?

Patients who do not have Neurogenic Detrusor Overactivity (NDO). This is a condition where the bladder muscle contracts too much due to nerve problems.
Patients who are not between the ages of 2 and 18 years old.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are taking other medications that might interfere with the study medication.
Patients who have had recent surgery or medical procedures that might affect the study results.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to similar medications.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Children’s Hospital Zagreb	Zagreb	Croatia
Narodny Ustav Detskych Chorob	Bratislava	Slovakia
Institutul Clinic Fundeni	Bucharest	Romania
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Region Midtjylland	Aarhus	Denmark
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej	Bialystok	Poland
KBC Split	Split	Croatia
Bwrlw Kiajehaa Ucjpaaerjbfxw Sgrmcarm Vgjq	Riga	Latvia
Sqolkhyl Cgvxxt dw Ufynhnk pxeene Ctyie “vauea Sulyhctupr Cathvd	Bucharest	Romania
Jl Bednl Mypzpbk srtefa	Petrzalka	Slovakia
Hrfua Bpgptt Hw	Bergen	Norway
Urgpnkwijyhtyn Ccbcybw Kmlaauisy	Gdansk	Poland
Undtnmvasp Ov Asehasx	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	12.02.2024
Croatia	Recruiting	12.02.2024
Denmark	Recruiting	12.02.2024
Latvia	Not recruiting	12.02.2024
Lithuania	Recruiting	12.02.2024
Norway	Recruiting	12.02.2024
Poland	Recruiting	12.02.2024
Romania	Recruiting	12.02.2024
Slovakia	Recruiting	12.02.2024

Trial locations

Investigated drugs:

Vibegron

Vibegron is a medication being studied for its effectiveness in treating children and teenagers with a condition called neurogenic detrusor overactivity (NDO). This condition affects the bladder, causing it to contract uncontrollably, which can lead to urinary issues. The trial aims to see how well vibegron works in improving bladder control in young patients who use clean intermittent catheterization (CIC) to manage their condition.

Investigated diseases:

Neurogenic bladder

Neurogenic Detrusor Overactivity (NDO) – This condition occurs when there is an overactive bladder muscle due to nerve problems. It often results in involuntary bladder contractions, leading to symptoms such as frequent urination, urgency, and incontinence. The condition is commonly associated with neurological disorders like spinal cord injury or multiple sclerosis. Over time, the bladder may become less compliant, meaning it cannot stretch as well to hold urine. This can lead to increased pressure in the bladder, potentially affecting kidney function. Management focuses on improving bladder control and reducing symptoms.

Trial ID:

2024-513995-16-00

Protocol code:

URO-901-3007

NCT ID:

NCT05491525

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Safety and Effectiveness of Vibegron for Children Aged 2 to 17 with Neurogenic Bladder Overactivity Using Clean Intermittent Catheterization

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?