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. 2013 Jul 23;8(7):e69738. doi: 10.1371/journal.pone.0069738

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.

a

±LD indicates that trial design allowed levodopa to be added to the randomized treatment; the dose of rotigotine is expressed as the delivered dose.