See appendix for a complete list of participating investigators.
Article first published online: 28 JUL 2010
Published 2010 Wiley-Liss, Inc.
Volume 25, Issue 12, pages 1881–1887, 15 September 2010
How to Cite
Stocchi, F., Zappia, M., Dall'Armi, V., Kulisevsky, J., Lamberti, P. and Obeso, J. A. (2010), Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease. Mov. Disord., 25: 1881–1887. doi: 10.1002/mds.23206
Potential conflict of interest: This trial was a trial sponsored by Chiesi pharma Italy. F.S. and J.O. has served as a paid consultant for Chiesi pharma. The authors have complied with all rules regarding journal ghost-writing policies. The manuscript has been written by the authors, no ghost writer has been employed in preparing the manuscript. All the authors, but Valentina Dall'Armi, received a research grant from Chiesi Pharma for the conduction of the study.
- Issue published online: 8 SEP 2010
- Article first published online: 28 JUL 2010
- Manuscript Accepted: 30 MAR 2010
- Manuscript Revised: 30 OCT 2009
- Manuscript Received: 26 JAN 2009
- The data analysis and Anita Chadha-Patel
- levodopa methylester;
- motor fluctuations;
- Parkinson's disease;
- liquid formulation
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