A study to investigate how solifenacin fluid is taken up, how long it stays in the body and how effective and safe it is in treating children aged from 6 months to less than 5 years with symptoms of neurogenic detrusor overactivity.

A Phase 3, Open-Label, Baseline-controlled, Multi-center, Sequential Dose -Titration Study to Assess the Pharmacokinetics, Long-Term Efficacy and Safety of Solifenacin Succinate Suspension in Children from 6 months to less than 5 years of Age with Neurogenic Detrusor Overactivity - Marmoset

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003178-22-GB

Enrollment

Registered

2013-02-26

Start date

2013-04-17

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurogenic Detrusor Overactivity (NDO) MedDRA version: 17.0 Level: LLT Classification code 10012547 Term: Detrusor hyperreflexia System Organ Class: 100000004857

Interventions

Product Name: Solifenacin Succinate Product Code: YM905 Pharmaceutical Form: Oral suspension INN or Proposed INN: Solifenacin succinate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Documented diagnosis of NDO, confirmed by urodynamics -Practicing clean intermittent catherization (CIC) -Minimum weight of 6 kg -Male or female and 6 months to less than 5 years of age Are the trial subjects under 18? yes Number of subjects for this age range: 24 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Known genitourinary condition (other than NDO) that may cause incontinence -Bladder augmentation surgery -Current faecal impaction -Electro-stimulation therapy within 2 weeks prior to the visit -Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention. -Reflux grade 3 to 5 -Current UTI -If the child is being breast-fed by a woman taking any prohibited medication or is fed with a milk product in which the presence of prohibited medication ingredients cannot be excluded

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term efficacy, safety, and pharmacokinetics (PK) of solifenacin succinate suspension after multiple dose administration.;Secondary Objective: Not applicable; Primary end point(s): Change from baseline in maximum cystometric capacity (Primary efficacy variable) ;Timepoint(s) of evaluation of this end point: Week 24	—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy: ·Secondary urodynamic efficacy variables ·Secondary diary ·Quality of life Safety PK variables ;Timepoint(s) of evaluation of this end point: At each study visit	—

Countries

Belgium, Canada, Denmark, France, Germany, Korea, Republic of, Netherlands, Philippines, Poland, United Kingdom

Contacts

Public ContactService Desk - Global Development

Astellas Pharma Europe B.V.

contact@astellas.com+31715455878

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026