BOTOX® for Treatment of Urinary Incontinence in patients 12-17 yrs old
Research type
Research Study
Full title
BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
IRAS ID
150158
Contact name
Andrew Baird
Contact email
Sponsor organisation
Allergan Ltd.
Eudract number
2014-000464-17
Clinicaltrials.gov Identifier
Research summary
Following the development of BOTOX for use in adults with urinary incontinence due to OAB, the purpose of this study is to investigate the safety and effectiveness of BOTOX® injections into the bladder of children that have accidental loss of urine due to Overactive Bladder. In this study, patients will receive 25 U, 50 U, or 100 U BOTOX and will have the opportunity to receive multiple treatments over approximately 2 years, with the possibility of dose increases based on patient response. The paediatric population to be studied, following discussion with the US Food and Drug Administration (FDA), was defined as patients aged 12 to 17 years.
The doses selected in this paediatric study provide a sufficient range to assess dose-response while not exceeding the adult dose of 100 U BOTOX. In addition, an upper cap of 6 U/kg BOTOX is in place to ensure maintenance of a safety margin based on nonclinical studies.
To date, no dose-ranging studies have been conducted in the paediatric OAB population.
In addition to evaluating the optimal dose of BOTOX in this patient population, this study is designed to collect long-term safety and efficacy data from repeated treatments over a period of approximately 2 years.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0302
Date of REC Opinion
17 Jun 2014
REC opinion
Further Information Favourable Opinion