12-week, multicenter, double-blind, randomized, placebo-controlled, parallel-groupstudy to investigate the efficacy, pharmacodynamic and safety of two doses of alfuzosin (0.1 mg/kg/day; 0.2 mg/kg/day) in the treatment of children and adolescents 2 – 16 years of age with elevated detrusor leak point pressure of neuropathic etiology followed by a 40-week open-label extension - Alfachi

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

-Children and adolescents of either gender 2 – 16 years of age with elevated detrusor LPP of neuropathic etiology
-Detrusor leak point pressure > or = 40 cm H2O and < 100 cm H2O
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

-Patients who had an urological surgery in the last 4 months prior to the study
-Patients who have undergone urethral dilatation in the last 3 months prior to the baseline urodynamic assessment
-Patients who have received a-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment
-Patients who have received any detrusor injections of botulinum toxin
- Patients with urological diseases/conditions other than functional bladder obstruction of neuropathic etiology that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele)
-Patients with a history of severe respiratory, cardiovascular, gastrointestinal, metabolic, hepatic, neurologic, endocrine, or renal disease or other serious disorders, which would interfere with the interpretation of the study results (e.g.high grade of vesicoureteral reflux)
-Patients or parents/legally authorized representatives who are illiterate or are judged to be unable to understand the nature, scope and possible consequences of the study
-History of intolerance to a-blocker therapy
-History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome)
-QTcF > 450 msec at screening electrocardiogram (ECG)
-History of unexplained loss of consciousness
-Orthostatic hypotension
-Patients who have taken potent cytochrome P450-3A4 inhibitors in the last 4 weeks prior to the study
-Pregnant or breast-feeding females and females of childbearing potential not protected by effective contraceptive methods of birth control.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of alfuzosin in comparison to placebo on the detrusor leak<br>point pressure (LPP) in children and adolescents 2 – 16 years of age with elevated<br>detrusor leak point pressure of neuropathic etiology and detrusor LPP > or = 40 cm H2O;Primary end point(s): Detrusor leak point pressure (LPP) evaluated at baseline and week 12.;Secondary Objective: -To investigate the safety and tolerability of two doses of alfuzosin in comparison to placebo in children and adolescents<br>-To evaluate the effects of the two doses of alfuzosin in comparison to placebo on :<br>Detrusor compliance<br>Urinary tract infection<br>-To investigate the pharmacokinetics of alfuzosin (population kinetics) after 12, 26 and 52 weeks of treatment<br>-To evaluate the 12-month long-term safety of alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day

Secondary Outcome Measures