The SALIVA (Sialanar® plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) study
In May 2021, the first child was enrolled into the SALIVA study, a trial sponsored by Proveca Pharma Ltd.
The SALIVA study is a double-blind randomised controlled trial comparing Sialanar® with placebo, both in addition to standard of care.1 A total of 80 children with severe drooling (sialorrhoea) related to chronic neurological disorders will participate from 14 centres in France. Recruitment is currently ongoing in the centres.
The primary objective of the SALIVA study is to measure the efficacy of Sialanar® versus placebo after 84 days, while secondary objectives are to evaluate tolerability and assess quality of life. After day 84, participants will be invited into a 6-month, open-label study extension, where patients initially randomised to Sialanar® will continue treatment and patients randomised to placebo will receive Sialanar®.
“Drooling is a common and distressing condition in children with chronic neurological disorders,” said Prof Fayoux, ENT surgeon at Lille University Hospital, the trial’s lead investigator.
“ The SALIVA study provides a unique opportunity to specifically assess the effects of Sialanar®, which is an oral formulation of glycopyrronium purposely developed to address the needs of children and their carers. In addition to efficacy and safety, investigating the impact of Sialanar® on the children’s quality of life is particularly important,” said Dr Helen Shaw, co-founder and Chief Medical Director of Proveca Pharma.
Full product information on Sialanar® can be found here: https://www.ema.europa.eu/en/medicines/human/EPAR/sialanar®#product-information-section
Proveca is a European pharmaceutical company who specialise in the development and licensing medicines to address unmet medical needs for children.
Working with clinicians, parents, carers and children, Proveca are leading the way to provide licensed medicines that are tailored to children’s specific requirements.
- EU Clinical Trials Register, EudraCT Number: 2020-005534-15 Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005534-15/FR
Created October 2021