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Sialanar plus oral rehabilitation vs placebo for severe sialorrhoea in children with neurodisabilities
2020-005534-15Phase 4Completed
- Sponsor
- Proveca
- Start
- Dec 2020
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 4, randomised, double-blind trial in hypersalivation and Neurodevelopmental disorder (NDD) comparing Sialanar plus oral rehabilitation with Placebo plus oral rehabilitation (2 arms). Primary endpoint: Change in Drooling Impact Scale (DIS) between baseline and day 84. Started Dec 2020; status: completed.
02
Drugs
glycopyrronium
03
Conditions
hypersalivationNeurodevelopmental disorder (NDD)
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