Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Joanne Morrison


Contact details

4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
United Kingdom

Additional identifiers

EudraCT number

2013-000863-94 number

Protocol/serial number


Study information

Scientific title

A single blind study comparing the efficacy of Glycopyrronium and Hyoscine on drooling in children with neurodisability - DRI Trial (Drooling Reduction Intervention)



Study hypothesis

Drooling is a common problem in children with neurodisabilities such as cerebral palsy or Down Syndrome. Drooling leads to the facial skin becoming sore, frequent changes of clothes, damage to educational equipment, and often social embarrassment for the child and family. There is no evidence about the relative effectiveness of the two medications most commonly used to reduce drooling.

This study aims to identify:
- whether Glycopyrronium or Hyoscine is more effective and at what dose
- side-effects of the medications and how these relate to dose

Over 9 months paediatricians, with special interest in neurodisability working in 15 UK centres, will recruit 90 children from outpatient clinics; these children will not have received any medication for drooling. Children will have a non-progressive neurodisability and be less that 16 years old. They will have no contraindications to the medications. Children will be randomised for treatment and medication will be increased, as tolerated for 4 weeks; this will be under the guidance of the Trial Research Paediatrician, working to the study protocol.

The Trial Outcome Assessor will collect outcome data before the intervention and then at 4, 12 and 52 weeks. Well established scales of the impact of the medication on family and child will be used. Children of sufficient age and ability (identified with help of local paediatrician and the family) will be asked for their own views in an interview.

The results will lead to guidance on: drug doses, intervals for increasing medication, and monitoring of adverse effects. The results have the potential to be adopted immediately because the medications are already in use and surveys of parents and professionals, before the study started, indicates that this trial is needed and the results anticipated with interest.

The overall study duration will be 2 years.

Ethics approval


Study design

Randomised interventional trial; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases


Primary Intervention, Commencement of Glycopyrronium oral medication or Hyoscine patch.
Secondary intervention, Adjustments to dosing of Glycopyrronium or Hyoscine.
Tertiary Intervention, Appointment to decide on ongoing treatment after 12 weeks.

Intervention type



Phase IV

Drug names

Glycopyrronium, Hyoscine

Primary outcome measure

Drooling Impact Scale score at 4 weeks

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Treatment naive children, with nonprogressive neurodisability, who require Glycopyrronium or Hyoscine to reduce drooling
2. No contraindication to either medication
3. Age between 36 months and below 16 years; Target Gender: Male & Female

Participant type


Age group




Target number of participants

Planned Sample Size: 90; UK Sample Size: 90

Participant exclusion criteria

1. Children who have received medical or surgical interventions for drooling
2. Children with medical conditions for which either medication is contraindicated
3. Children whose parents are considered unable to follow the study protocol
4. Parents without mobile or home telephone (required for communication with research registrar and assistant)
5. Parents whose use of English would not allow them to understand the issues in the 6. Consent form or be able to take part in the phone calls with the Trial Research Paediatrician and Trial Outcome Assessor

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

4th Floor William Leech Building
Newcastle Upon Tyne
United Kingdom

Sponsor information


Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

New Victoria Wing
Queen Victoria Road
Newcastle Upon Tyne
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Castang Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Royal College of Paediatrics and Child Health (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies


United Kingdom

Funder name

WellChild Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2014 protocol in:
2017 results in:

Publication citations

  1. Protocol

    Parr JR, Weldon E, Pennington L, Steen N, Williams J, Fairhurst C, O'Hare A, Lodh R, Colver A, The drooling reduction intervention trial (DRI): a single blind trial comparing the efficacy of glycopyrronium and hyoscine on drooling in children with neurodisability., Trials, 2014, 15, 60, doi: 10.1186/1745-6215-15-60.

Additional files

Editorial Notes

15/02/2018: Publication reference added.