Glycopyrrolate Improves Disability From Sialorrhea in Parkinson's Disease: A 12‐Week Controlled Trial

Objective The objective of this study was to assess the 12‐week efficacy and safety of oral glycopyrrolate for moderate‐to‐severe sialorrhea in Parkinson's disease (PD). Background Chronic moderate‐to‐severe sialorrhea has a negative impact on quality of life in PD. There is no robust evidence for oral treatments for sialorrhea longer than 1 week. Methods This was a 12‐week, double‐blinded, placebo‐controlled, parallel phase II study in patients with PD and Movement Disorder Society–Unified Parkinson's Disease Rating Scale item 2.2 > 2. The intervention was glycopyrrolate up to 4.5 mg/d; the primary outcome was sialorrhea related–disability (Radboud Oral Motor Inventory for Parkinson's Disease–Saliva). We used an intention‐to‐treat analysis. A P  < 0.05 was deemed significant. Results We recruited 28 patients (age, 71.1 ± 6.9 years; PD duration, 11.4 ± 7.2 years; Radboud Oral Motor Inventory for Parkinson's Disease–Saliva, 22.4 ± 5.7). Glycopyrrolate was superior to placebo at 12 weeks in the Radboud Oral Motor Inventory for Parkinson's Disease–Saliva (between‐group difference, 5.3; 95% confidence interval, 1.0–9.6). Dry mouth was the most common adverse event (glycopyrrolate, n = 6; placebo, n = 2). Conclusions The results support the efficacy of glycopyrrolate to treat sialorrhea‐related disability up to 12 weeks and contribute to addressing unmet nonmotor care needs in PD. © 2020 International Parkinson and Movement Disorder Society