Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease |
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Authors: | Fabrizio Stocchi MD PhD Mario Zappia MD Valentina Dall'Armi MSc Jaime Kulisevsky MD Paolo Lamberti MD José Angel Obeso MD |
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Institution: | 1. Department of Neuroscience, Institute of Neurology, IRCCS San Raffaele Pisana, Roma 00163, Italy;2. Neuroscience Department, University of Catania, Catania 95123, Italy;3. Department of Clinical and Molecular Epidemiology, IRCCS San Raffaele Pisana, Roma 00163, Italy;4. Neurology Department, Movement Disorders Unit, Fundació de G. S. de l'Hospital de la Santa Creu Sant Pau, Barcelona, Spain;5. Department of Neurology, Ospedale Policlinico Consorziale, Bari 70124, Italy;6. Department of Neurology, Neurology, Clinica Universitaria de Navarra, Pamplona 31008, Spain |
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Abstract: | Melevodopa hydrochloride plus carbidopa in effervescent tablets (M/C) is a readily soluble antiparkinsonian tablet formulation. A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double‐blind, double‐dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention‐to‐treat population) between the two groups was not statistically significant (P = 0.07): ?39.4 minutes (95%CI: ?67.08 to ?11.73) in M/C group vs. +3.5 minutes (95%CI: ?36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups M/C: 2 patients (1.3%); L/C: 1 patient (1.4%)]. This study failed to meet the primary endpoint (P = 0.07); however, there was a trend in favour of the M/C preparation, which deserves further attention. © 2010 Movement Disorder Society |
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Keywords: | melevodopa levodopa methylester motor fluctuations Parkinson's disease liquid formulation |
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