Study identification

EU PAS number

EUPAS103644

Study ID

103945

Official title and acronym

A study to assess utilisation and safety of Glycopyrronium Bromide 1mg/5ml Oral Solution as licensed for symptomatic treatment of severe sialorrhoea in children and adolescents aged 3 years and older with chronic neurological disorders in the UK

DARWIN EU® study

No

Study countries

United Kingdom

Study description

A prospective cohort study to assess the utilisation and safety of Glycopyrronium Bromide 1mg/5ml oral solution for treatment of severe sialorrhoea in children and adolescents aged 3 years and older with chronic neurological disorders in the UK. Paediatric prescribers/centres will be recruited to the study and children who have been prescribed Glycopyrronium Bromide as advised/prescribed by the recruited paediatricians will be identified over a 30 month recruitment period. Primary and secondary data will be collected on these patients over a 12 month observation period using electronic data capture. Summary descriptive statistics and incident risk/rate estimates for adverse events will be produced. Time to onset of adverse events and follow up consultations will be summarised.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Saad Shakir

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Colonis
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)