A double-blind, randomized, placebo and active-controlled study of nebicapone for the treatment of motor fluctuations in Parkinson's disease.

CNS Neuroscience & Therapeutics
Joaquim J FerreiraBIA-3202-202 Study Investigators

Abstract

To determine the efficacy, safety and tolerability of nebicapone, a new catechol-O-methyltransferase inhibitor for the treatment of motor fluctuations in Parkinson's disease (PD), we conducted a multicenter, randomized, 8-week double-blind, placebo- and active-controlled, parallel-group study comparing nebicapone 50 mg, 100 mg, or 150 mg, entacapone 200 mg (active control) or placebo administered concomitantly with levodopa/carbidopa or levodopa/benserazide. Two hundred and fifty-two PD patients with motor fluctuations treated with levodopa/carbidopa or levodopa/benserazide (4-8 daily doses) were enrolled and 250 patients were eligible for intention-to-treat (ITT) analysis on the basis of having at least one efficacy assessment. The primary endpoint was 8-week change from baseline in absolute "Off" time duration noted in self-scoring diaries. At 8 weeks of treatment the mean daily "Off" time decreased significantly compared to placebo for nebicapone 150 mg (-106 min; 95%CI: -192; -21) and entacapone 200 mg (-81 min; 95%CI: -142; -19). The decrease in "Off" time with nebicapone 50 mg or 100 mg did not reach statistical significance. Treatment-emergent adverse events were reported by 32% to 49% of patients in any treatment group,...Continue Reading

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Citations

Dec 12, 2012·Journal of Neural Transmission·Manuela PilleriAngelo Antonini
Jul 7, 2015·Biomedical Chromatography : BMC·Daniela GonçalvesAmílcar Falcão
Jan 17, 2014·Expert Review of Neurotherapeutics·Manuela Pilleri, Angelo Antonini
Oct 3, 2013·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Amaal AlDakheelAnthony E Lang
Jul 10, 2012·Current Opinion in Neurology·Werner PoeweJoseph Jankovic
Jan 25, 2020·Neurobiology of Disease·Aaron D SchwabR Lee Mosley

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