Table 3.

Review of existing double-blind, randomized, placebo-controlled phase II or III trials assessing the effect of rotigotine on motor functions

Study	Phase	Countries	Maintenance phase (weeks)	Rotigotine dose (mg/24 h)	Dosing strategya	Sample sizeb	Control group	Reference
In early-stage Parkinson’s disease
PATCH I/SP506	IIb	USA, Canada	7	2–4–6–8	Fixed	206/242	Placebo	[24]
SP512	III	USA, Canada	24	2–6	Optimal	201/277	Placebo	[25, 26]
SP513	III	UK, Germany, Israel and others	33	2–8	Optimal	409/561	Ropinirole, placebo	[27]
–	–	Japan	4	2–16	Optimal	155/180	Placebo	[29]
SP914/NCT01646268	III	China	24	2–8	Optimal	220/249	Placebo	[28]
In advanced-stage Parkinson’s disease
PREFER/SP650	III	USA, Canada	24	8–12	Fixed	260/351	Placebo	[33]
CLEOPATRA-PD/SP515/NCT00244387	III	Germany	16	4–16	Optimal	415/506	Pramipexole, Placebo	[34]
SP921/NCT00522379	III	USA, Chile, Mexico, Peru, India	12	2-4-6-8	Fixed	406/514	Placebo	[32]
NCT01628848	II	Japan	4	16	Fixed	148/174	Placebo	[31]
NCT01628926	III	Japan	4	2–16	Optimal	354/420	Ropinirole, Placebo	[35]
SP1037/NCT01646255	III	China	12	4–16	Optimal	311/346	Placebo	[30]

^aOptimal or fixed-dose design

^bSubjects completed trial/subjects randomized