Analysing the use of glycopyrronium bromide for excessive drooling in young children

Retrospective analysis of real-world evidence on the use of glycopyrronium bromide in children under 3 years of age with sialorrhea

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17293938

Enrollment

100

Registered

2024-10-24

Start date

2023-08-25

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

Sialorrhoea Digestive System

Interventions

This is an observational, retrospective, cohort study of enteral glycopyrronium bromide administered for the symptomatic treatment of severe sialorrhoea in patients below 3 years of age, using inform

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged from birth to less than 30 months of age at the time that glycopyrronium bromide was commenced 2. Treated with glycopyrronium bromide for sialorrhoea (or equivalent terminology) via the enteral route

Exclusion criteria

Exclusion criteria: 1. Treatment with glycopyrronium bromide for other reasons than sialorrhoea 2. Aged 30 months or over at the time that glycopyrronium bromide was commenced 3. Glycopyrronium bromide given by a route other than the enteral route

Design outcomes

Primary

Measure	Time frame
There is no primary outcome measure. The study was not powered for a primary outcome measure - all outcome measures are described in the secondary outcomes	—

Secondary

Measure	Time frame
The following secondary outcome measures will be assessed using data collected in the REDcap database at one timepoint: 1. Number of participants with adverse events, where causality has been attributed to glycopyrronium bromide 2. Number of participants with serious adverse events, where causality has been attributed to glycopyrronium bromide 3. Number of participants with glycopyrronium bromide dose reductions due to adverse events 4. Number of participants with glycopyrronium bromide discontinuation due to adverse events 5. A change in a drooling severity scale such as the Drooling Impact Scale (DIS), Modified Teacher's Drooling Scale (mTDS) or other relevant scales. In the absence of any formal rating scale or any other terminology/description/indication that there has been no change, an improvement, or worsening of drooling or sialorrhoea symptoms will be reviewed. 6. Number of participants where glycopyrronium bromide is discontinued due to treatment failure	—

Measure

Time frame

The following secondary outcome measures will be assessed using data collected in the REDcap database at one timepoint: 1. Number of participants with adverse events, where causality has been attributed to glycopyrronium bromide 2. Number of participants with serious adverse events, where causality has been attributed to glycopyrronium bromide 3. Number of participants with glycopyrronium bromide dose reductions due to adverse events 4. Number of participants with glycopyrronium bromide discontinuation due to adverse events 5. A change in a drooling severity scale such as the Drooling Impact Scale (DIS), Modified Teacher's Drooling Scale (mTDS) or other relevant scales. In the absence of any formal rating scale or any other terminology/description/indication that there has been no change, an improvement, or worsening of drooling or sialorrhoea symptoms will be reviewed. 6. Number of participants where glycopyrronium bromide is discontinued due to treatment failure

—

Countries

England, United Kingdom

Contacts

Public ContactJames Moss

jamesmoss@proveca.com+44 (0)1614682627

Outcome results

None listed

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