Clinical efficacy of a single afternoon dose of effervescent levodopa-carbidopa preparation (CHF 1512) in fluctuating Parkinson disease.
A possible cause of motor fluctuations in patients with Parkinson disease is the erratic drug absorption. In a randomized double-blind double-dummy study of melevodopa (levodopa methyl ester), a highly soluble levodopa pro-drug plus carbidopa (CHF 1512) was compared to a standard formulation of levodopa/carbidopa (LD/CD) in 74 fluctuating Parkinson disease patients. The first afternoon, LD/CD tablet was substituted with an equimolar dose of CHF 1512. The study lasted 4 weeks and was followed by an 8-week (optional) open phase. The primary efficacy variable was latency to "on." Patients randomized to receive CHF 1512 had a significative shorter latency to "on" than those randomized to LD/CD and a similar "on" duration. The safety profile of CHF 1512 was also comparable with LD/CD.
Stocchi
Fabrizio
F
Institute of Neurology, IRCCS San Raffaele Pisana, Rome, Italy. stocchi@sanraffaele.it
Fabbri
Laura
L
Vecsei
Laszlo
L
Krygowska-Wajs
Anna
A
Monici Preti
Piero Alessandro
PA
Ruggieri
Stefano A
SA
D000203:Activities of Daily Living; D000368:Aged; D000978:Antiparkinson Agents; D002230:Carbidopa / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007980:Levodopa / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D009043:Motor Activity / Q000187:drug effects; D019957:Motor Skills Disorders / Q000209:etiology / Q000517:prevention & control; D009325:Nausea / Q000139:chemically induced; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy*
D000978:Antiparkinson Agents; D004338:Drug Combinations; D007980:Levodopa; C035420:levodopa methyl ester; D002230:Carbidopa