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 50 mg once-daily compared with placebo, which will require further evaluation.

Otiker, Tal (författare)
Vasist, Lakshmi S (författare)
Gibson, Rachel A (författare)
Sarai, Bhopinder K (författare)
Barton, Matthew E (författare)
Richards, Duncan B (författare)
Hellström, Per M.,1954-Uppsala universitet,Gastroenterologi/hepatologi(Swepub:uu)perhe742 (författare)
Nyholm, DagUppsala universitet,Neurologi(Swepub:uu)danyh856 (författare)
Dukes, George E (författare)
Burn, David J (författare)
Uppsala universitetGastroenterologi/hepatologi (creator_code:org_t)

Av författaren/redakt...: Marrinan, Sarah ...; Otiker, Tal; Vasist, Lakshmi ...; Gibson, Rachel A; Sarai, Bhopinder ...; Barton, Matthew ...; visa fler...; Richards, Duncan ...; Hellström, Per M ...; Nyholm, Dag; Dukes, George E; Burn, David J; visa färre...

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Neurologi

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