Baseline of double-blind study | Change at end of year 1 (as observed) | Change at end of year 1 (LOCF) | Change at end of year 2 (as observed) | Change at end of year 2 (LOCF) | ||||
---|---|---|---|---|---|---|---|---|
N | Score | N | Score | Score | N | Score | Score | |
IRLS total score | 295 | 27.8 ± 5.9 | 220 | -18.8 ± 8.8 | -17.4 ± 9.9 | 190 | -17.2 ± 9.2 | -15.4 ± 10.3 |
RLS-6 | ||||||||
Satisfaction with sleep | 293 | 7.2 ± 2.5 | 216 | -4.5 ± 3.4 | -4.1 ± 3.5 | 190 | -4.3 ± 3.3 | -3.7 ± 3.4 |
Severity at bedtime | 293 | 6.0 ± 3.0 | 215 | -4.6 ± 3.2 | -4.2 ± 3.3 | 189 | -4.0 ± 3.1 | -3.8 ± 3.2 |
Severity during the night | 294 | 6.8 ± 2.7 | 216 | -5.2 ± 3.0 | -4.9 ± 3.1 | 190 | -4.9 ± 3.0 | -4.5 ± 3.2 |
Severity during the day when resting | 293 | 4.9 ± 2.6 | 216 | -3.4 ± 2.6 | -3.4 ± 2.7 | 190 | -2.9 ± 2.7 | -2.9 ± 3.0 |
Severity during the day when active | 294 | 1.9 ± 2.0 | 217 | -1.4 ± 1.9 | -1.5 ± 2.0 | 190 | -1.2 ± 2.0 | -1.2 ± 2.2 |
Daytime tiredness or sleepiness | 294 | 4.8 ± 2.6 | 217 | -2.8 ± 2.9 | -2.6 ± 3.1 | 190 | -2.4 ± 2.7 | -2.2 ± 3.0 |
CGI-1 (severity of illness) | 295 | 5.1 ± 0.9 | 217 | -2.9 ± 1.2 | -2.8 ± 1.3 | 191 | -2.8 ± 1.2 | -2.6 ± 1.4 |
QoL-RLS total score | 273 | 30.2 ± 10.4 | 200 | -19.1 ± 12.2 | -17.7 ± 13.2 | 178 | -17.7 ± 12.8a | -15.8 ± 13.8a |
ESS total score | 289 | 6.7 ± 5.2 | 215 | -1.5 ± 4.5 | n.d. | 185 | -0.8 ± 4.6 | -0.6 ± 4.6 |