Retrospective analysis of glycopyrronium use in children under 3
Research type
Research Study
Full title
Retrospective analysis of real-world evidence on the use of glycopyrronium bromide in children under 3 years of age with sialorrhea
IRAS ID
325926
Contact name
Louise Bracken
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Duration of Study in the UK
0 years, 7 months, 7 days
Research summary
Alder Hey Children's NHS Foundation Trust will act as Sponsor. Proveca Ltd are the funder of this study, and are a UK-based pharmaceutical company which specialises in the development and licensing of medicines to address unmet medical needs in children. In 2016, Proveca Ltd received a Paediatric Use Marketing Authorisation for Sialanar® (glycopyrronium bromide) for the treatment of severe drooling in children and adolescents aged 3 years and older with chronic neurological disorders. The licence was initially developed for those 3 years of age and over.
This study is intended to collect retrospective real world data on the use of glycopyrronium bromide in children under 3 years old, which is not covered by the current license. It is hoped that the data will allow for a retrospective analysis of the safety and efficacy of glycopyrronium bromide in this age group, with the intention of extending the Sialanar® licence. This would give the younger patients access to a licensed product to help manage their drooling.The study procedures are limited to the review of the existing medical records of participants from birth to 3 years of age treated with glycopyrronium bromide for sialorrhoea (excessive drooling).
REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0427
Date of REC Opinion
15 May 2023
REC opinion
Favourable Opinion