Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)

Summary

This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses and patch sizes).

Timeline

Start

2003-07

Primary completion

2009-04

Completion

2009-04

Publications

• Results Oertel WH, Benes H, Garcia-Borreguero D, Geisler P, Hogl B, Trenkwalder C, Tacken I, Schollmayer E, Kohnen R, Stiasny-Kolster K; Rotigotine SP710 Study Group. One year open-label safety and efficacy trial with rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome. Sleep Med. 2008 Dec;9(8):865-73. doi: 10.1016/j.sleep.2008.04.012. Epub 2008 Aug 26.
• Results Hogl B, Oertel WH, Stiasny-Kolster K, Geisler P, Benes H, Garcia-Borreguero D, Trenkwalder C, Poewe W, Schollmayer E, Kohnen R. Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch. BMC Neurol. 2010 Sep 28;10:86. doi: 10.1186/1471-2377-10-86.
• Results Oertel W, Trenkwalder C, Benes H, Ferini-Strambi L, Hogl B, Poewe W, Stiasny-Kolster K, Fichtner A, Schollmayer E, Kohnen R, Garcia-Borreguero D; SP710 study group. Long-term safety and efficacy of rotigotine transdermal patch for moderate-to-severe idiopathic restless legs syndrome: a 5-year open-label extension study. Lancet Neurol. 2011 Aug;10(8):710-20. doi: 10.1016/S1474-4422(11)70127-2. Epub 2011 Jun 24.
• Dohin E, Hogl B, Ferini-Strambi L, Schollmayer E, Fichtner A, Bauer L, Garcia-Borreguero D. Safety and efficacy of rotigotine transdermal patch in patients with restless legs syndrome: a post-hoc analysis of patients taking 1 - 3 mg/24 h for up to 5 years. Expert Opin Pharmacother. 2013 Jan;14(1):15-25. doi: 10.1517/14656566.2013.758251. Epub 2012 Dec 21.
• Hogl B, Oertel WH, Schollmayer E, Bauer L. Transdermal rotigotine for the perioperative management of restless legs syndrome. BMC Neurol. 2012 Sep 25;12:106. doi: 10.1186/1471-2377-12-106.

Drugs

Indications