A Randomized, Double-Blind, Placebo-Controlled Trial of Camicinal in Parkinson's Disease

被引:12
|
作者
Marrinan, Sarah L. [1 ,2 ]
Otiker, Tal [3 ]
Vasist, Lakshmi S. [4 ]
Gibson, Rachel A. [3 ]
Sarai, Bhopinder K. [5 ]
Barton, Matthew E. [4 ]
Richards, Duncan B. [5 ]
Hellstrom, Per M. [6 ]
Nyholm, Dag [7 ]
Dukes, George E. [4 ]
Burn, David J. [8 ]
机构
[1] NHS Lothian, Royal Infirm Edinburgh, Edinburgh, Midlothian, Scotland
[2] Newcastle Univ, Inst Ageing & Hlth, Newcastle Upon Tyne, Tyne & Wear, England
[3] GlaxoSmithKline R&D, Stevenage, Herts, England
[4] GlaxoSmithKline R&D, Res Triangle Pk, NC USA
[5] GlaxoSmithKline, Cambridge, England
[6] Uppsala Univ, Dept Med Sci, Uppsala, Sweden
[7] Uppsala Univ, Dept Neurosci, Neurol, Uppsala, Sweden
[8] Newcastle Univ, Inst Neurosci, Newcastle Upon Tyne, Tyne & Wear, England
关键词
Parkinson's disease/parkinsonism; Clinical trials Randomized controlled (CONSORT agreement); MOTOR FLUCTUATIONS; LEVODOPA; PHARMACOKINETICS; CISAPRIDE;
D O I
10.1002/mds.27259
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
引用
收藏
页码:329 / 332
页数:4
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