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Mov Disord. 2018 Feb;33(2):329-332. doi: 10.1002/mds.27259. Epub 2017 Dec 26.

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

Author information

1
Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, United Kingdom.
2
Newcastle University, Institute of Ageing and Health, Newcastle upon Tyne, United Kingdom.
3
GlaxoSmithKline R&D, Stevenage, United Kingdom.
4
GlaxoSmithKline R&D, Research Triangle Park, North Carolina, United States.
5
GlaxoSmithKline, Cambridge, United Kingdom.
6
Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
7
Department of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden.
8
Newcastle University, Institute of Neurosciences, Newcastle upon Tyne, United Kingdom.

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

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