1. Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease
- Author
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Stocchi, F, Zappia, Mauro, Dall'Armi, V, Kulisevsky, J, Lamberti, P, Obeso, Ja, Melevodopa Plus Carbidopa Study Group (Ruggieri, Stocchi, Toso, Bartolomei, Onofrj, Thomas, Nordera, Valzania, Tropeani, Bonuccelli, Del, Dotto, Gigli, Brotini, Scarzella, Tamma, Caputo, Piccolo, Albanese, Abbruzzese, Martignoni, Riboldazzi, Calandrella, Scaglioni, Bianchi, Lamberti, Zappia, Bracco, Barone, P, Amboni, M, Trianni, Toni, Pezzoli, Meucci, Sacilotto, Obeso, Rodriguez, Oroz, Tolosa, Pilleri, Kulisevsky, Pascual, Campolongo, Gonzalez, Maldonado, Chacón, García, Moreno, Velazquez, Lopez, Castro, Sesar, Catalán, Del, Val, Pin, Vela, Mateo, Castaño, Vivancos, Martinez, Pondal, Linazasoro, Van, Blercom, Lezcano, Rouco, Gómez, Esteban, and Burguera, Bataller)
- Subjects
Adult ,Aged, 80 and over ,Male ,Analysis of Variance ,Administration, Oral ,Carbidopa ,Parkinson Disease ,Middle Aged ,Drug Administration Schedule ,Intention to Treat Analysis ,Antiparkinson Agents ,Levodopa ,Drug Combinations ,Treatment Outcome ,Double-Blind Method ,Humans ,Female ,Aged - 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.
- Published
- 2010