Comparison of the efficacy and safety of Sialanar plus oral rehabilitation against placebo plus oral rehabilitation for children and adolescents with drooling and neurodisabilties

Phase 1

• Conditions: Severe sialorrhoea and neurodisabilties in children; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2020-005534-15-FR
• Lead Sponsor: Proveca Pharma LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-24
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Children aged = 3 years old and < 18 years old.
2.Children with chronic neurological disorders (such as polyhandicap, cerebral palsy, Angelman syndrome, Rett’s syndrome, epilepsy, amyotrophic lateral sclerosis and mental retardation)
3.Diagnosis of severe sialorrhoea due to a chronic neurological disorder as assessed by a modified Teachers Drooling Scale (mTDS) = 6.
4.DIS Scale = 50. Impact of drooling as assessed by drooling impact scale.
5.Children who have completed at least 3 months of non-pharmacological standard of care treatment (i.e. rehabilitation e.g. intraoral stimulation and oral facial exercise).
6.Children with stable drooling for the past 4 weeks.
7.Written consent form signed by parents (or, when applicable, the subject’s legally acceptable representative).
8.Affiliated or beneficiary of a social security scheme.
9.A nominated parent or carer who can commit to complete parent / carer questionnaires, with good ability to understand and speak French.

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
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.Children unwilling to provide assent to participate in the study. (children who are unable to provide assent should be considered eligible).
2.Botulinum injection for sialorrhoea given within 6 months of enrolment.
3.Any anticholinergic therapy used in the previous 4 weeks.
4.Scopoderm patch used in the previous 4 weeks.
5.History of surgery for drooling in the previous 12 months.
6.Children prescribed non-permitted concomitant medication as defined in section 7.2.2
7.Children in whom anticholinergics are contraindicated such as those with glaucoma, myasthenia gravis, urinary retention, severe renal impairment, history of intestinal obstruction, ulcerative colitis, paralytic ileus, pyloric stenosis or hypersensitivity to the active substance or the excipient.
8.On-going or programmed orthodontic treatment over the study period.
9.Untreated oro-mandibular dystonia (isolated lingual dystonia accepted), clinical gastro oesophageal reflux, dental inflammatory condition (dental caries, gingivitis…).
10.Family and carers unable to commit to the schedule of the study protocol.
11.Female patients who are lacting or pregnant
12.Female patients who are planning a pregnancy within the study period
13.Patients having participated in another clinical study within at least 30 days or within 5 half-lives of last dose of IMP (whichever is longer).

Study & Design

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