A randomized, double-blind, placebo-controlled trial of camicinal in Parkinson's disease
| Autor: | George E. Dukes, Dag Nyholm, Bhopinder K. Sarai, Lakshmi S. Vasist, Sarah L Marrinan, Matthew E. Barton, Duncan Richards, Per M. Hellström, David J. Burn, Tal Otiker, Rachel A. Gibson |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty Parkinson's disease Neurology Clinical trials Randomized controlled (CONSORT agreement) Neurologi Placebo-controlled study Rivastigmine Absorption (skin) Gastroenterology Piperazines Statistics Nonparametric Double blind Antiparkinson Agents Levodopa 03 medical and health sciences 0302 clinical medicine Double-Blind Method Piperidines Internal medicine medicine Humans Gait Aged Aged 80 and over Analysis of Variance Gastric emptying Dose-Response Relationship Drug business.industry Brief Report Parkinson's disease/parkinsonism Parkinson Disease Middle Aged medicine.disease Parkinson's disease parkinsonism 030104 developmental biology Treatment Outcome Area Under Curve Brief Reports Female Neurology (clinical) business 030217 neurology & neurosurgery Follow-Up Studies |
| Zdroj: | Movement Disorders |
| Popis: | Background: Delayed gastric emptying may impairʟ-dopa absorption, contributing to motor fluctuations. We evaluated the effect of camicinal (GSK962040), a gastroprokinetic, on the absorption ofʟ-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:ʟ-dopa exposure was similar with coadministration of camicinal compared to placebo. Median time to maximumʟ-dopa concentration was reduced, indicating more rapid absorption ofʟ-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 ofʟ-dopa. This study provides evidence of an improvement of the motor response toʟ-dopa in people with PD treated with camicinal 50 mg once‐daily compared with placebo, which will require further evaluation. |
| Databáze: | OpenAIRE |
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