Table 3.
Efficacy of RTG in RLS – change from baseline ± SD (P-value)
| Study, dose | n | IRLS total score ± SD (P-value) | CGI-1 score ± SD (P-value) | PSQI total score ± SD (P-value) |
|---|---|---|---|---|
| Inoue et al40 | ||||
| 2 mg | 95 | −14.3±8.9 (0.030) | – | −3.1±3.2 (0.188) |
| 3 mg | 94 | −14.6±9.0 (0.016) | – | −3.2±3.3 (0.112) |
| Plo | 95 | −11.6±8.2 | – | −2.5±2.4 |
| Oertel et al24 | ||||
| 2 mga | 41 | −16.5±9.3 | −2.7±1.4 | – |
| Plo | 20 | −9.9±9.9 | −1.7±1.5 | – |
| Hening et al10 | ||||
| 0.5 mg | 98 | −10.9±8.9 (0.0682) | 4.7±0.8 (0.0603) | – |
| 1 mg | 99 | −11.1±9.3 (0.0535) | 4.6±0.7 (0.0857) | – |
| 2 mg | 95 | −13.4±9.2 (0.0002) | 4.7±0.8 (0.0007) | – |
| 3 mg | 103 | −14.3±9.4 (<0.0001) | 4.7±0.8 (<0.0001) | – |
| Plo | 99 | −9.0±7.7 | 4.7±0.6 | – |
| Trenkwalder et al8 | ||||
| 1 mg | 148 | −14.0±0.8 (<0.0001) | −2.13±0.12 (<0.0001) | – |
| 2 mg | 96 | −16.4±1.0 (<0.0001) | −2.41±0.14 (<0.0001) | – |
| 3 mg | 92 | −16.8±1.1 (<0.0001) | −2.55±0.17 (<0.0001) | – |
| Plo | 111 | −8.7±0.9 | −1.37±0.15 | – |
| Oertel et al9 | ||||
| 0.5 mg | 50 | −10.5±9.2 (0.2338) | −1.6±1.4 | – |
| 1 mg | 64 | −15.3±10.0 (0.0004) | −2.2±1.5 (<0.05) | – |
| 2 mg | 49 | −15.7±9.5 (0.0003) | −2.4±1.3 (<0.05) | – |
| 3 mg | 64 | −17.3±10.5 (<0.0001) | −2.7±1.6 (<0.05) | – |
| 4 mg | 53 | −14.9±10.3 (0.0013) | −2.3±1.5 (<0.05) | – |
| Plo | 53 | −9.3±9.6 | −1.5±1.4 | – |
| Stiasny-Kolster41 | ||||
| 1.125 mg | 19 | −10.5±2.0 | – | – |
| 2.25 mg | 13 | −12.3±2.3 | – | – |
| 4.5 mg | 17 | −15.7±1.9 | – | – |
Note: aA mean dose of RTG in the treatment group was reported as 2.1 mg/24 hours.
Abbreviations: RTG, rotigotine; RLS, restless legs syndrome; SD, standard deviation; IRLS, International Restless Legs Syndrome Study Group severity rating scale; CGI-1, Clinical Global Impressions item-1; PSQI, Pittsburgh Sleep Quality Index; Plo, placebo.