Rotigotine Restless Legs Syndrome Dose Finding Trial

Summary

The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936) will be more effective than placebo. The tolerability and safety of rotigotine will be assessed.

Timeline

Start

2003-04

Primary completion

2004-02

Completion

2004-02

Outcome

Met primary endpoint

paper The hierarchical statistical test procedure demonstrated superiority of rotigotine over placebo for 4mg/24h, 3mg/24h, 2mg/24h, and 1mg/24h, with p-values of 0.0013, <0.0001, 0.0003, and 0.0004, respectively. PMID 17553743 ↗

Publications

• Results Oertel WH, Benes H, Garcia-Borreguero D, Geisler P, Hogl B, Saletu B, Trenkwalder C, Sommerville KW, Schollmayer E, Kohnen R, Stiasny-Kolster K; Rotigotine SP 709 Study Group. Efficacy of rotigotine transdermal system in severe restless legs syndrome: a randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe. Sleep Med. 2008 Mar;9(3):228-39. doi: 10.1016/j.sleep.2007.04.010. Epub 2007 Jun 5.

Drugs

Indications