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. 2008 May;6(3):253–262. doi: 10.1370/afm.845

Table 1.

Clinical Trial Characteristics

Reference Design N Baseline IRLS Mean+SD Follow-up (weeks) Drug/Dose Adjusted Mean Difference IRLS Mean+SE Treatment CGI-I Responder Rate (%) Jadad Score
Allen (2004)17 P, R, DB, PC 55 N/A 12 Ropinirole 0.25–4.0 mg/d –1.2±2.1 Ropinirole=17/32 (53)
Placebo=17/33 (52)
3
Stiasny-Kolster (2004)18 P, R, DB, PC 63 25.0 ± 5.0 1 Rotigotine 1.125–4.5 mg/24 h N/A Rotigotine=34/49 (69)
Placebo=6/14 (43)
4
Trenkwalder (2004)19 P, R, DB, PC 284 24.4 ± 5.8 12 Ropinirole 0.25–4.0 mg/d –3.0±1.1 Ropinirole=78/146 (53)
Placebo=56/138 (41)
4
Walters (2004)20 P, R, DB, PC 267 23.6 ± 5.9 12 Ropinirole 0.25–4.0 mg/d –2.5±1.1 Ropinirole=78/131 (60)
Placebo=53/135 (39)
5
Bogan (2006)21 P, R, DB, PC 381 22.0 ± 5.0 12 Ropinirole 0.25–4.0 mg/d –3.7±0.9 Ropinirole=137/187 (73)
Placebo=109/193 (56)
5
Inoue (2006)22 P, R, DB, PC 41 N/A 6 Pramipexole 0.125–0.75 mg/d –11.5±3.0 Pramipexole=16/20 (80)
Placebo=11/21 (52)
3
Partinen (2006)23 P, R, DB, PC 107 22.7 ± 4.1 3 Pramipexole 0.125–0.75 mg/d –9.2±1.7 Pramipexole=65/86 (76)
Placebo=9/21 (43)
3
Winkelman (2006)24 P, R, DB, PC 339 23.4 ± 5.1 12 Pramipexole 0.25–0.75 mg/d –4.3±1.1 Pramipexole=183/254 (72)
Placebo=44/85 (52)
4
Garcia-Borreguero (2007)25 P, R, DB. PC 270 25.4 8 Sumanirole 0.5–4.0 mg/d N/A Sumanirole=104/212 (49)
Placebo=26/51 (51)
3
Oertel (2007)26 P, R, DB. PC 341 28.0 ± 6.3 6 Rotigotine 0.5–4 mg/24 h N/A Rotigotine=212/280 (76)
Placebo=29/53 (55)
5
Oertel (2007)27 P, R, DB. PC 338 24.7 ± 5.2 6 Pramipexole 0.125–0.75 mg/d –6.6±1.1 Pramipexole=141/224 (63)
Placebo=37/114 (32)
3
RRL10001328 P, R, DB, PC 359 26.0 ± 4.4 12 Ropinirole 0.5–6.0 mg/d –4.1±1.0 Ropinirole=124/175 (71)
Placebo=92/184 (50)
4
ROP10189229 P, R, DB, PC 298 23.5 ± 6.2 12 Ropinirole 0.25–4.0 mg/d N/A Ropinirole=92/152 (61)
Placebo=76/146 (52)
4
SKF10146830 P, R, DB, PC 54 26.6 ± 5.3 7 Ropinirole 0.25–4.0 mg/d –9.9±2.9 N/A 3

CGI-I = Clinical Global Impression – Improvement scale; DB = double-blind; IRLS = International Restless Legs Syndrome Study Group scale; N/A=not available; P=prospective; PC=placebo control; R=randomized.