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 50mg once-daily compared with placebo, which will require further evaluation. (c) 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.