Effect of pramipexole on RLS symptoms and sleep: A randomized, double-blind, placebo-controlled trial

Improving sleep for patients with restless legs syndrome. Part II: meta-analysis of vibration therapy and drugs approved by the FDA for treatment of restless legs syndrome

“…As mentioned earlier, standardized differences in mean sleep change scores from baseline between treated and control patients were not significantly influenced by trial duration (Table 2). This observation is consistent with the temporal response dynamics of RLS severity scores observed in the drug trials included in the meta-analysis data [43][44][45][46][47][48][49][50][51][52][53][54][55] and is exemplified by data from a 26-week pramipexole trial reported by Hogl et al ( Figure 5), 65 which show consistent superiority of drug treatment over placebo beginning at the first week of treatment and extending to week 26. Thus, inclusion of trials of different duration in the current meta-analysis is justified because there is no meaningful change in the difference between treated and control subjects from week 1 to week 26.…”

“…Summary data from 12 of these drug trials were obtained from the peer-reviewed articles, with some supplementary data from manufacturers' websites. [43][44][45][46][47][48][49][50][51][52][53][54] Data for the remaining trial was available only on the manufacturer's website. 55 Description of selected trials receiving investigational treatment and 1645 controls.…”

“…All trials were randomized, concurrent, parallel, prospective, and double-blind, and included patients with at least moderately severe primary RLS. [43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58] Patients were between 18-79 years old, with symptoms limited to the legs.…”

Change of International Restless Legs Syndrome Study Group Rating Scale subscales with treatment and placebo: a pilot study

“…de la Fuente-Fernández et al 35 and de la Fuente-Fernandez et al and Stoess l36 found a placebo effect in Parkinson's disease that was related to the release of substantial amounts of endogenous dopamine. However, it is difficult to compare these pharmaceutical placebo responses to the ones found in our study, since most of them are conducted over a 12-week 30,31 or even longer trial periods 37 because the placebo response increases with time. 32 A metaanalysis of the placebo effect in RLS treatment studies 32 found a substantial placebo response rate, more so for the IRLS than for other IRLS severity measuring tools.…”

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Gabapentin Enacarbil in Subjects with Restless Legs Syndrome

“…20 The reductions in IRLS total score observed in the present study are also comparable with those reported for dopamine agonists that are currently approved for treatment of RLS. [31][32][33][34][35] A significant mean reduction in IRLS total score from baseline was also reported with GEn 600 mg (-13.8) compared with placebo (-9.8), and a greater proportion of GEn 600 mg-treated subjects were rated by investigators as CGI-I responders (72.8% compared with 44.8%, respectively). These results contrast with findings from a 2-week study of GEn 600 mg reported by Walters et al that demonstrated a nonsignificant mean reduction from baseline in IRLS total score at Week 2 LOCF (-9.1) compared with placebo (-8.9), and no significant difference in the proportion of CGI-I responders (GEn 600 mg, 58.6%; pla- jects in the present study reported significant sleep disturbance at baseline on the MOS Sleep Scale domains compared with a healthy cohort sample of the US population.…”