Combining ethanol with clipping of the submandibular duct to treat drooling in children with neurodisabilities

Phase 1

Active, not recruiting

• Conditions: Drooling or sialorrhea; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-004057-23-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-30
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1.Moderate to severe drooling indicated by Drooling Frequency Score = 3 or Drooling Severity Score = 2.
2.Aged 10 years and older.
3.Cerebral palsy or any other non-progressive neurodevelopmental disability.
4.Contra-indications for a SMDR, or rejection towards a SMDR by patient or caregiv-ers*
5.Ability and willingness to follow the study protocol and attend the 8 and 32-weeks vis-its.
6.Written and informed consent from caregivers, and when appropriate, oral consent from the child.
* contra-indication for SMDR:
- posterior drooling
- pharyngeal dysphagia as judged by the speech and language therapist.
- progressive neurodisability as judged by the child neurologist.

Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Medical history of salivary gland abnormalities like ductal stenosis, strictures
2.Previous submandibular salivary gland surgery, or other contraindications for surgery or general anesthesia.
3.Recent (<6 months) glandular Botulinum Neurotoxin A (BoNT-A) injection
4.Simultaneous alternative treatment for drooling.

Study & Design

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