title: Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease.
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.
authors.affiliation: Department of Neuroscience, Institute of Neurology, IRCCS San Raffaele Pisana, Roma, Italy. fabrizio.stocchi@fastwebnet.it
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Stocchi
authors.forename: Mario
authors.initials: M
authors.lastname: Zappia
authors.forename: Valentina
authors.initials: V
authors.lastname: Dall'Armi
authors.forename: Jaime
authors.initials: J
authors.lastname: Kulisevsky
authors.forename: Paolo
authors.initials: P
authors.lastname: Lamberti
authors.forename: José Angel
authors.initials: JA
authors.lastname: Obeso
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000627:therapeutic use; D002230:Carbidopa / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D007980:Levodopa / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000978:Antiparkinson Agents; D004338:Drug Combinations; D007980:Levodopa; C035420:levodopa methyl ester; D002230:Carbidopa