Efficacy and safety of rotigotine in Japanese patients with restless legs syndrome: a phase 3, multicenter, randomized, placebo-controlled, double-blind, parallel-group study

Inoue, Yuichi; Shimizu, Tetsuo; Hirata, Koichi; Uchimura, Naohisa; Ishigooka, Jun; Oka, Yasunori; Ikeda, Junji; Tomida, Takayuki; Hattori, Nobutaka

doi:10.1016/j.sleep.2013.07.007

Cited by 21 publications

(30 citation statements)

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“…23 Rotigotine. It is highly likely that the rotigotine patch improves RLS symptoms as measured by the IRLS (2 Class I 26,27 and 3 Class II studies, [28][29][30] up to 6 months in duration). It is likely that rotigotine improves PLMS (1 Class I study 27 ), but there is insufficient evidence to support or refute an effect on other objective sleep measures (1 Class I study 27 that is not statistically significant but whose CIs include clinically important effects).…”

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confidence: 99%

Practice guideline summary: Treatment of restless legs syndrome in adults

et al. 2016

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Practice guideline summary: Treatment of restless legs syndrome in adults

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“…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.…”

Section: Therapeutic Efficacy Of Rotigotine Transdermal Patchmentioning

confidence: 99%

“…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].…”

Section: Therapeutic Efficacy Of Rotigotine Transdermal Patchmentioning

confidence: 99%

“…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].…”

Section: Therapeutic Efficacy Of Rotigotine Transdermal Patchmentioning

confidence: 99%

“…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].…”

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Rotigotine Transdermal Patch: A Review in Restless Legs Syndrome

Garnock-Jones

2016

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Rotigotine transdermal patch (Leganto(®), Neupro(®)) is indicated for the treatment of restless legs syndrome (RLS); this article reviews the pharmacological properties of rotigotine transdermal patch and its clinical efficacy and tolerability in patients with RLS. The transdermal patch allows for a continuous, stable release of rotigotine (avoiding first-pass metabolism), which in turn leads to continuous receptor stimulation, believed to closely mimic physiological striatal dopamine receptor function. In short-term and 6-month studies, especially at the higher dosages of 2 and 3 mg/24 h, rotigotine transdermal patch was generally associated with a significantly greater improvement in IRLS total score and CGI-S total score than placebo, and rotigotine recipients were generally more likely to respond to treatment and enter remission. In noncomparative extension studies, efficacy was sustained for ≤5 years. Rotigotine transdermal patch is generally well tolerated, and appears to have a tolerability profile that is similar to that of other non-ergolinic dopamine-receptor agonists. The most common adverse events in clinical trials included application-site reactions, nausea, headache and asthenic conditions. The drug has a relatively low risk of clinically significant augmentation of restless legs syndrome symptoms. In conclusion, rotigotine transdermal patch offers continuous administration of the drug in a daily treatment, and is a useful treatment option in patients with RLS.

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Treatment of restless legs syndrome: Evidence‐based review and implications for clinical practice (Revised 2017)^§

et al. 2018

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The objective of the current review was to update the previous evidence-based medicine review of treatments for restless legs syndrome published in 2008. All randomized, controlled trials (level I) with a high quality score published between January 2007 and January 2017 were reviewed. Forty new studies qualified for efficacy review. Pregabalin, gabapentin enacarbil, and oxycodone/naloxone, which did not appear in the previous review, have accrued data to be considered efficacious. Likewise, new data enable the modification of the level of efficacy for rotigotine from likely efficacious to efficacious. Intravenous ferric carboxymaltose and pneumatic compression devices are considered likely efficacious in idiopathic restless legs syndrome. Bupropion and clonidine were reviewed, but the lack of data determined a rating of insufficient evidence for efficacy. The following interventions continue to be considered efficacious as in 2008: levodopa, ropinirole, pramipexole, cabergoline, pergolide, and gabapentin. Bromocriptine, oxycodone, carbamazepine, and valproic acid are considered likely efficacious. Oral iron is nonefficacious in iron-sufficient subjects, but its benefit for patients with low peripheral iron status has not been adequately evaluated. Restless legs syndrome augmentation has been identified as a significant long-term treatment complication for pramipexole more than pregabalin and possibly for all dopaminergic agents more than α2δ ligands. Therefore, special monitoring for augmentation is required for all dopaminergic medications as well as tramadol. Other drugs also require special safety monitoring: cabergoline, pergolide, oxycodone, methadone, tramadol, carbamazepine, and valproic acid. Finally, we also highlighted gaps and needs for future clinical research and studies of restless legs syndrome. © 2018 International Parkinson and Movement Disorder Society.

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Efficacy and safety of rotigotine in Japanese patients with restless legs syndrome: a phase 3, multicenter, randomized, placebo-controlled, double-blind, parallel-group study

Cited by 21 publications

References 29 publications

Practice guideline summary: Treatment of restless legs syndrome in adults

Practice guideline summary: Treatment of restless legs syndrome in adults

Rotigotine Transdermal Patch: A Review in Restless Legs Syndrome

Treatment of restless legs syndrome: Evidence‐based review and implications for clinical practice (Revised 2017)^§

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Efficacy and safety of rotigotine in Japanese patients with restless legs syndrome: a phase 3, multicenter, randomized, placebo-controlled, double-blind, parallel-group study

Cited by 21 publications

References 29 publications

Practice guideline summary: Treatment of restless legs syndrome in adults

Practice guideline summary: Treatment of restless legs syndrome in adults

Rotigotine Transdermal Patch: A Review in Restless Legs Syndrome

Treatment of restless legs syndrome: Evidence‐based review and implications for clinical practice (Revised 2017)§

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Treatment of restless legs syndrome: Evidence‐based review and implications for clinical practice (Revised 2017)^§