Efficacy and safety of the dopamine agonist rotigotine (RTG) was investigated in patients with moderate to severe idiopathic restless legs syndrome (RLS), including daytime symptoms. Three fixed doses of rotigotine (1.125 mg, 2.25 mg, and 4.5 mg) and placebo were applied by patches (size, 2.5 cm² per 1.125 mg) in a double-blind, randomized, parallel-group, multicenter, 1-week, proof-of-principle trial. The primary efficacy measure was the total score on the International Restless Legs Syndrome Scale (IRLS). Additionally, the RLS-6 scale, the Clinical Global Impressions (CGI), and a sleep diary were used. Of 68 enrolled patients, 63 (mean age, 58±; 9 years; 64% women) were randomly assigned. RLS severity improved related to dose by 10.5 (1.125 mg RTG/die; P = 0.41), 12.3 (2.25 mg RTG/die; P = 0.18), and 15.7 points (4.5 mg RTG/die; P < 0.01) on the IRLS compared to placebo (8 points). According to the RLS-6 scales, daytime symptoms significantly improved with all rotigotine doses. The CGI items supported the favorable efficacy of the 4.5-mg dose. Skin tolerability of the patches and systemic side effects were similar between rotigotine and placebo. This pilot study suggests that continuous delivery of rotigotine by means of a patch may provide an effective and well-tolerated treatment of RLS symptoms both during night and day. © 2004 Movement Disorder Society

References

1 Stiasny K, Ueberall M, Oertel WH, for the German Cabergoline Study Group Cabergoline in RLS. A double-blind placebo-controlled multicenter dose-finding trial. Neurology 2002; 58: A435.
2Ferrini- Strambi L, Oldani A, Castronovo V, Zucconi M. RLS augmentation and pramipexole long-term treatment. Neurology 2001; 56( Suppl. 3): A 20.
3 Trenkwalder C, Brandenburg U, Hundemer H-P, et al. A randomized long-term placebo-controlled multicenter trial of pergolide in the treatment of restless legs syndrome with central evaluation of polysomnographic data. Neurology 2004; 62: 1391–1397.
4 Stiasny K, Roebbecke J, Schü P, Oertel WH. Treatment of idiopathic restless legs syndrome (RLS) with the D2-agonist cabergoline - an open clinical trial. Sleep 2000; 23: 349–354.
5 Wetter TC, Stiasny K, Winkelmann J, et al. A randomized controlled study of pergolide in patients with restless legs syndrome. Neurology 1999; 52: 944–950.
6 Winkelmann J, Wetter TC, Stiasny K, Oertel WH, Trenkwalder C. Treatment of restless leg syndrome with pergolide--an open clinical trial. Mov Disord 1998; 13: 566–569.
7 Becker PM, Ondo W, Sharon D. Encouraging initial response of restless legs syndrome to pramipexole. Neurology 1998; 51: 1221–1223.
8 Allen R, Picchietti D, Hening W, et al. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institute of Health. Sleep Med 2003; 4: 101–119.
9 Earley CJ. Restless legs syndrome. N Engl J Med 2003; 348: 2103–2109.
10 Stiasny K, Oertel WH, Trenkwalder C. Clinical symptomatology and treatment of restless legs syndrome and periodic limb movement disorder. Sleep Med Rev 2002; 6: 253–265.
11 Comella C. Restless legs syndrome: treatment with dopaminergic agents. Neurology 2002; 58( Suppl. 1): 87–92.
12 Chesson AL, Wise M, Davila D, et al. Practice parameters for the treatment of restless legs syndrome and periodic limb movement disorder. Sleep 1999; 22: 961–968.
13 Hening W, Allen R, Earley C, Kushida C, Picchietti D, Silber M. The treatment of restless legs syndrome and periodic limb movement disorder - an American Academy of Sleep Medicine Review. Sleep 1999; 22: 970–998.
14 Tuite P, Riss J. Recent developments in the pharmacological treatment of Parkinson's disease. Expert Opin Invest Drugs 2003; 12: 1335–1352.
15 The International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs. Sleep Med 2003; 4: 121–132.
16 Hening W, Allen R, [editorial]. Restless legs syndrome (RLS): the continuing development of diagnostic standards and severity measures. Sleep Med 2003; 4: 95–97.
17 Kohnen R, Oertel WH, Stiasny-Kolster K, Benes H, Trenkwalder C. Severity rating of restless legs syndrome: review of ten years experience with the RLS-6 scales in clinical trials. Sleep 2003; 26: A342.
18 National Institute of Mental Health. 028CGI: Clinical global impressions. In: W Guy, editor. ECDEV assessment manual for psychopharmacology. Volumes 1–6. Rockville, MD: National Institute for Mental Health; 1976. p 218–222.
19 Walters AS. Toward a better definition of the restless legs syndrome. The International Restless Legs Syndrome Study Group. Mov Disord 1995; 10: 634–642.
20 Benes H, Kurella B, Kummer J, Kazenwadel J, Selzer R, Kohnen R. Rapid onset of action of levodopa in restless legs syndrome: a double-blind, randomised, multi-center, crossover trial. Sleep 1999; 22: 1073–1081.
21 Trenkwalder C, Stiasny K, Pollmächer T, et al. L-dopa therapy of uremic and idiopathic restless legs syndrome: a double-blind, crossover trial. Sleep 1995; 18: 681–688.
22Garcia- Borreguero D, Montagna P, Trenkwalder C, Group obotRRS. Ropinirole is effective in the treatment of restless legs syndrome: a double-blind placebo-controlled 12-week study conducted in 10 countries. Neurology 2003; 60( Suppl. 1): A11.
23 Walters AS, Ondo W, Sethi K, Dreykluft T, Grunstein R. Ropinirol versus placebo in the treatment of restless legs syndrome (RLS): 12-week multicenter placebo-controlled study conducted in 6 countries. Sleep 2003; 26: A344.
24Garcia- Borreguero D, Larrosa O, de la Llave Y, Verger K, Masramon X, Hernandez G. Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study. Neurology 2002; 59: 1573–1579.

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Volume19, Issue12

December 2004

Pages 1432-1438

Patch application of the dopamine agonist rotigotine to patients with moderate to advanced stages of restless legs syndrome: A double-blind, placebo-controlled pilot study

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Patch application of the dopamine agonist rotigotine to patients with moderate to advanced stages of restless legs syndrome: A double-blind, placebo-controlled pilot study

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