Effects of rotigotine on daytime symptoms in patients with primary restless legs syndrome: a randomized, placebo-controlled study

Abstract

Rotigotine was beneficial in improving overall RLS symptom severity (assessed by IRLS) and RLS symptom severity at various times of the day (m-SIT-DS); however, superiority to placebo was not established.

Rotigotine Transdermal Patch: A Review in Restless Legs Syndrome

“…Studies assessing polysomnography endpoints required a PLM index (PLMI) score C15 [30,31], and RENALYS required patients to have comorbid end-stage renal disease requiring haemodialysis [31]. Exclusion criteria included secondary RLS [26,[28][29][30] or conditions that cause secondary RLS [27].…”

“…Further inclusion criteria were a previous response to dopaminergic therapy or no previous RLS treatment [27][28][29][30][31], and RLS symptoms on C2 days/week for two consecutive weeks before study entry [27]. Patients in RESTORE were also required to have an average Multiple Suggested Immobilization Test (m-SIT) Discomfort Scale (m-SIT-DS; a measure of RLS symptoms throughout the day) score C1.5 over the course of the m-SIT testing period at baseline and a score of 'severe' or 'very severe' on IRLS Item 8 [26]. Studies assessing polysomnography endpoints required a PLM index (PLMI) score C15 [30,31], and RENALYS required patients to have comorbid end-stage renal disease requiring haemodialysis [31].…”

“…RLS was diagnosed based on International Restless Legs Syndrome Study Group (IRLSSG) criteria [26][27][28][29][30][31]; moderate to severe disease was defined as an IRLSSG Severity Rating Scale (IRLS) score C15 [26][27][28][29][30][31] and a Clinical Global Impressions-Severity (CGI-S) score C4 [26,[28][29][30][31]. Further inclusion criteria were a previous response to dopaminergic therapy or no previous RLS treatment [27][28][29][30][31], and RLS symptoms on C2 days/week for two consecutive weeks before study entry [27].…”

“…Adult patients with (idiopathic [26][27][28][29][30]) moderate to severe RLS were randomized to receive rotigotine (at an allocated dosage of 0.5-3 mg/24 h [27][28][29] or a personalized optimal dosage of 1-3 mg/24 h [26,30,31]; see Table 1 for details) or placebo for a 2-to 8-week [26,27,30,31] or 6-month [28,29] maintenance period. Patients underwent a B3-to 5-week titration period before the maintenance period began [26][27][28][29][30][31]. Discussion focuses on the approved dosage range of 1-3 mg/24 h [5].…”

“…While several phase II studies investigating the efficacy of rotigotine transdermal patch in patients with RLS have been completed (including a pilot study [23], a dose-finding study [24], and a study in Japanese patients [25]), this section focuses on data from randomized, double-blind, placebo-controlled, multicentre, phase III studies, including a daytime-symptoms study (RESTORE) [26], a study in Japanese patients [27], two large 6-month studies (SP0792 [28] and SP0790 [29]), and two sleep-laboratory studies (SP0794 [30] and RENALYS [31]). Adult patients with (idiopathic [26][27][28][29][30]) moderate to severe RLS were randomized to receive rotigotine (at an allocated dosage of 0.5-3 mg/24 h [27][28][29] or a personalized optimal dosage of 1-3 mg/24 h [26,30,31]; see Table 1 for details) or placebo for a 2-to 8-week [26,27,30,31] or 6-month [28,29] maintenance period.…”