A randomized, double-blind, placebo-controlled trial of camicinal in Parkinson's disease
Sarah L Marrinan, Tal Otiker, Lakshmi S Vasist, Rachel A Gibson, Bhopinder K Sarai, Matthew E Barton, Duncan B Richards, Per M Hellström, Dag Nyholm, George E Dukes, David J Burn, Sarah L Marrinan, Tal Otiker, Lakshmi S Vasist, Rachel A Gibson, Bhopinder K Sarai, Matthew E Barton, Duncan B Richards, Per M Hellström, Dag Nyholm, George E Dukes, David J Burn
Abstract
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.
Trial registration: ClinicalTrials.gov NCT01602549.
Keywords: Clinical trials Randomized controlled (CONSORT agreement); Parkinson's disease/parkinsonism.
© 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.
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Source: PubMed