A randomized, double‐blind, placebo‐controlled trial of camicinal in Parkinson's disease

Background: Delayed gastric emptying may impair l‐dopa absorption, contributing to motor fluctuations. We evaluated the effect of camicinal (GSK962040), a gastroprokinetic, on the absorption of l‐dopa and symptoms of PD. Methods: Phase II, double‐blind, placebo‐controlled trial. Participants were randomized to receive camicinal 50 mg once‐daily (n = 38) or placebo (n = 20) for 7 to 9 days. Results: l‐dopa exposure was similar with coadministration of camicinal compared to placebo. Median time to maximum l‐dopa concentration was reduced, indicating more rapid absorption of l‐dopa. Camicinal resulted in significant reduction in OFF time (–2.31 hours; 95% confidence interval: –3.71, –0.90), significant increase in ON time (+1.88 hours; 95% confidence interval: 0.28, 3.48) per day, and significant decrease in mean total MDS‐UPDRS score (–12.5; 95% confidence interval: –19.67, ‐5.29). Camicinal treatment was generally well tolerated. Conclusions: PD symptom improvement with camicinal occurred in parallel with more rapid absorption of l‐dopa. This study provides evidence of an improvement of the motor response to l‐dopa in people with PD treated with camicinal 50 mg once‐daily compared with placebo, which will require further evaluation. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.