Table 3.
Studies with pramipexole in adult RLS patients
| Study | Trial/study design | Measures | Patients | Duration | Dosage | Primary outcomes | Secondary outcomes |
|---|---|---|---|---|---|---|---|
| Lin et al (1998) | Open-label | Visual analog scale | 15 out of 16 patients (94%) completed study
Symptomatic RLS Treatment-resistant RLS |
2–3 mo | Mean dose 0.3 mg/d | Suppresses RLS symptoms | Suppresses daytime augmentation |
| Becker et al (1998) | Open-label clinical | Short IRLSSG | 23 moderate to severe resistant RLS patients (primary and secondary) (19 completed trial) | 1–5 mo | Single dose of 0.125 mg (nighttime symptoms); 0.125 mg bid/tid (daily symptoms)
Mean dose of 0.35+0.15 mg/d (Dallas); 1.6+1.0 mg/d (Houston) |
Significant improvement | |
| Montplaisir (1999) | Double-blind, randomized, crossover with placebo control | RLS severity home questionnaire
Polysomnogram |
10 out of 11 subjects completed trial | 4 wk of trials with 2-wk washout period | 0.375 mg/d increased up to 1.5 mg/d vs placebo | Effective in treating sensory and motor symptoms of RLS
0.375–0.75 mg completely eradicated RLS in 9 patients Decrease in PLMS by 98% |
No improvement in sleep continuity, efficiency, sleep latency, TST, number of awakenings |
| Galvez-Jimenez et al (1999) | Observational | IRLSSG | 4 resistant RLS patients (primary and secondary) | Mean of 8.9 mo (1.5–12 mo) | Average dose of 0.75 mg/d | Control of symptoms without any significant side-effects or need of medication adjustment | Difficulty initiating or maintaining sleep unimproved |
| Montplaisir (2000b) | Follow-up for long-term efficacy | Home questionnaire | 7 RLS patients | Mean follow-up duration of 7.8 mo | 0.25 mg/d increased to optimal dose | Efficacy throughout 24 h with a single dose at bedtime | Long-lasting beneficial effect on RLS symptoms |
| Saletu et al (2002) | Single-blind, placebo-controlled crossover | IRLSSG
Polysomnography Psychometry Zung Depression and Anxiety Scale |
11 patients with primary RLS
10 patients completed 4-week follow-up |
After night (acute)
4-wk follow-up |
Acute after night dose of 0.27 mg/d
4 wk trial mean dose of 0.28±0.1 mg/d |
Total scores of the IRLSSG improved
Significant decrease in PLMs/h |
Improved sleep efficiency and quality compared to placebo
Significant decrease in PSQI–QOL Daytime sleepiness and depression improved |
| Quality of Life Index
Pittsburgh SleepQuality Index Epworth Sleepiness Scale | |||||||
| Silber et al (2003) | Retrospective review | 60 consecutive RLS patients | Mean of 27.2 mo | Median initial dose of 0.38 mg/d | Completely effective in 2 out of 3 patients; ineffective in 7% | ||
| Manconi et al (2003) | Open-label without placebo-control group | Suggested Immobilization Test
IRLSSG |
24 never treated primary (20) and secondary RLS patients | 30–60 d (mean 39 d) after optimal dosage | 0.25–0.50 mg/d | Significantlyimproved the subjective RLS symptoms and IRLSSGRS scores | Significant decrease in mean movement index |
| Ondo et al (2004) | Follow-up | Subjective report by patients | 52 out of 83 patients with nonuremic RLS | 39.2+20.9 mo (7–101 mo) | 0.79+0.55 mg/d | Effectively treat RLS | |
| Stiasny-Kolster et al (2004) | Short-term open label | IRLSSG
Polysomnography |
17 patients with severe primary RLS
(13 patients resistant to levodopa) |
4 wk | 0.125–0.75 mg/d (a mean of 0.3+0.2 mg) | Rapid complete or pronounced relief of RLS symptoms
Worsening of RLS symptoms under levodopa recovered Significant improvement in PLM index, PLMA index |
Significantly improved sleep by reduction in sleep onset latency, increase in TST, increase in sleep efficiency |
| Miranda et al (2004) | Follow-up | IRLSSG
Polysomnography (8 patients) |
10 uremic RLS patients | 1 mo | Mean dose of 0.25 mg/d (0.125–0.5 mg/d) | Decrease in mean severityscale score
Decrease in PLMW index |
No changes in sleep latency, TST, number of awakenings, or sleep efficiency |
| Partinen et al (2004) | Large randomized double-blind, placebo-controlled, dose-finding | 109 patients with RLS | NS | 0.5–0.75 mg/d vs placebo | Significant decrease in severity of symptoms | ||
Abbreviations: d, day; h, hour; IRLSSG, International RLS Study Group questionnaire; mo, months; NS, not significant; PLMS, periodic leg movement during sleep; PLMA, periodic leg movements sleep arousal index; PLMW, periodic leg movements while awake; PSQI–QOL, Pittsburgh Sleep Quality Index -quality of life; RLS, restless legs syndrome; TST, total sleep time; wk, weeks.