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

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

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Garcia-Borreguero, Diego Allen, Richard Hudson, John Dohin, Elisabeth Grieger, Frank Moran, Kimberly Schollmayer, Erwin Smit, René Winkelman, John
Description	Country affiliation: Spain Author Affiliation: Garcia-Borreguero D ( a a Sleep Research Institute , Madrid , Spain.); Allen R ( b b Department of Neurology , Johns Hopkins Bayview Medical Center , Baltimore , MD , USA.); Hudson J ( c c FutureSearch Trials of Neurology , Austin , TX , USA.); Dohin E ( d d UCB Pharma , Brussels , Belgium.); Grieger F ( e e UCB Pharma , Monheim am Rhein , Germany.); Moran K ( f f UCB Pharma , Smyrna , GA , USA.); Schollmayer E ( e e UCB Pharma , Monheim am Rhein , Germany.); Smit R ( g g UCB Pharma , Raleigh , NC , USA.); Winkelman J ( h h Massachusetts General Hospital , Boston , MA , USA.)
Abstract	OBJECTIVE: This 12 week double-blind, placebo-controlled study (ClinicalTrials.gov: NCT01569464) was conducted to evaluate the effects of rotigotine transdermal patch on daytime symptoms in patients with idiopathic restless legs syndrome (RLS). METHODS: Adult patients with moderate-to-severe RLS were randomized to rotigotine (optimal dose: 1-3 mg/24 h) or placebo. A modified four-assessment version (4:00 pm, 6:00 pm, 8:00 pm, and 10:00 pm) of the Multiple Suggested Immobilization Test (m-SIT) was performed at baseline and end of 4 week maintenance (EoM). Primary study outcomes were change from baseline to EoM in International Restless Legs Syndrome Rating Scale (IRLS) and in average of means for the m-SIT Discomfort Scale (m-SIT-DS) (combined average of mean values from each of the individual assessments). Secondary outcomes included average of means of Periodic Limb Movement during Wakefulness Index (PLMWI; PLM/hour) for the combination of m-SIT. RESULTS: A total of 150 patients were randomized and 137 (rotigotine: 92/101 [91.1%]; placebo: 45/49 [91.8%]) completed maintenance. All 150 randomized patients were assessed for efficacy. At EoM, mean change in IRLS was -14.9 ± 9.3 with rotigotine vs. -12.7 ± 7.6 with placebo (ANCOVA, LS mean treatment difference [95% CI]: -0.27 [-2.96, 2.42]; p = 0.8451). Changes in average of means of m-SIT-DS values of each individual SIT were comparable with rotigotine (-2.68 ± 2.31) vs. placebo (-2.62 ± 2.61) (ANCOVA, LS mean treatment difference [95% CI]: 0.07 [-0.61, 0.75]; p = 0.8336) and comparable reductions in PLMWI were observed in both treatment groups (8.34 [-8.50, 25.17]; p = 0.3290). Rotigotine was generally well tolerated. Application site reactions (rotigotine: 20 patients [19.8%]; placebo: 4 [8.2%]) and nausea (16 [15.8%]; 3 [6.1%]) were the most common AEs. CONCLUSIONS: 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.
File Format	HTM / HTML
ISSN	03007995
Issue Number	1
Volume Number	32
e-ISSN	14734877
Journal	Current Medical Research and Opinion
Language	English
Publisher	Taylor & Francis
Publisher Date	2016-01-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Medicine Dopamine Agonists Therapeutic Use Restless Legs Syndrome Drug Therapy Tetrahydronaphthalenes Thiophenes Adult Aged Double-blind Method Female Humans Male Middle Aged Adverse Effects Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Medicine

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