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.