Table 1. The main characteristics of the included randomized controlled trails.
Study, year | Study design (Jadad score) | Stage ofPD | Comparisona | Participants | Primary outcome data reported |
PSG, 2003 | MC DB Phase III RCT (5) | Early | Rotigotine vs Placebo (195/47),Rotigotine dose (mg/day): 2, 4,6, 8, Duration (w): 11 | Mean age (y): 61/62, Men (%):67/49, Duration of PD (y):1.2/1.3 | UPDRS ADL+Motor subtotal, dropouts, adverse events |
Jankovic, 2007 | MC DB Phase III RCT (4) | Early | Rotigotine vs Placebo (181/96),Rotigotine dose (mg/day):up to 6, Duration (w): 27 | Mean age (y): 62/65, Men (%):68/60, Duration of PD (y):1.3/1.4 | UPDRS ADL, Motor and subtotal, dropouts, adverse events |
Giladi, 2007 | MC DB Phase III RCT (5) | Early | Rotigotine vs Placebo (215/118),Rotigotine dose (mg/day):up to 8, Duration (w): 37 | Mean age (y): 61/60, Men (%): 55/58, Duration of PD (y): 1.4/1.2 | UPDRS ADL+Motor subtotal, dropouts, adverse events |
LeWitt, 2007 | MC DB Phase III RCT (5) | Advanced | Rotigotine+LD vs Placebo+LD(229/120), Rotigotine dose (mg/day):8, 12, Duration (w): 12 | Mean age (y): 66/66, Men (%):65/62, Duration of PD (y):7.7/7.7 | UPDRS ADL and Motor, dropouts, adverse events, “on” and “off” time |
Poewe, 2007 | MC DB Phase III RCT (5) | Advanced | Rotigotine+LD vs Placebo+LD(201/100), Rotigotine dose (mg/day):up to 16, Duration (w): 29 | Mean age (y): 64/65, Men (%):66/71, Duration of PD (y):8.9/8.5 | UPDRS ADL and Motor, dropouts, adverse events, “on” and “off” time |
Trenkwalder, 2011 | MC DB Phase III RCT (5) | Mixed | Rotigotine±LD vs Placebo±LD(191/96), Rotigotine dose(mg/day): up to 16, Duration(w): 23 | Mean age (y): 65/64, Men (%):64/44, Duration of PD (y):4.6/4.9 | UPDRS ADL and Motor, dropouts, adverse events |
Abbreviations: MC = multicenter; DB = double-blinded; vs = versus; RCT = randomized controlled trial; Y = year; W = week; UPDRS = unified Parkinson’s disease rating scale; LD = levodopa; ADL = activities of daily living; PSG = Parkinson study group.
±LD indicates that trial design allowed levodopa to be added to the randomized treatment; the dose of rotigotine is expressed as the delivered dose.