Trial of Glycopyrronium versus Hyoscine to treat drooling in childre

Phase 1

• Conditions: Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]; Excessive drooling in children with non-progressive neurodisability; MedDRA version: 14.1Level: PTClassification code 10013642Term: DroolingSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2013-000863-94-GB
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-02
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- Treatment naive children, with non-progressive neurodisability, who require Glycopyrronium or Hyoscine to reduce drooling
- No contra-indication to either medication
- Age between 36 months and below 16 years

Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify whether Glycopyrronium or Hyoscine is more effective in treating drooling in children with non-progressive disability;Secondary Objective: To determine the most effective dosing schedule to achieve optimum balance between clinical benefits and adverse effects.<br>To describe the reported satisfaction with medication treatment of drooling for children and carers.<br>;Primary end point(s): The primary clinical endpoint is the Drooling Impact Scale score at 4 weeks, at which time all children will be on the maximum tolerated dose of their medication. <br>(The two groups’ Drooling Impact Scale scores will be compared using an independent sample t-test.);Timepoint(s) of evaluation of this end point: Four weeks after start of medication

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in Drooling Impact Scale (DIS) score between baseline, 4 weeks, 12 weeks and 52 weeks.<br>2. Change in Drooling Severity-Frequency Scale (DSFS) score.<br>3. Difference between the groups in the Treatment Satisfaction Questionnaire for Medication (TSQM-version II) score<br>4. Final medication doses, as a percentage of child’s maximum dose, compared between the two groups.<br>5. Relationship between dose and adverse effects, investigated using survival analysis.<br>6. Children and young people’s perceptions of the effectiveness and acceptability of the medications, elicited in the semi-structured interview with the Trial Research Paediatrician.;Timepoint(s) of evaluation of this end point: 12 weeks and 52 weeks after start of medication